in-MAU-tion: Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients
Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT01078584
Collaborator
McKesson Canada (Other)
7,993
568
33
14.1
0.4
Study Details
Study Description
Brief Summary
The in-MAU-tion study is conducted to determine the percentage of hypertensive participants with or without diabetes reaching CHEP (Canadian Hypertension Education Program) defined blood pressure targets. Additionally, the study assesses change in renal function (microalbuminuria, estimated glomerular filtration rate) in hypertensive participants treated with trandolapril (Mavik®) and examines patient satisfaction with trandolapril (Mavik®) therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
There are no interventional implications in this study. The study runs under consideration of Canadian Hypertension Education Program guidelines and as per standard practice of care. Data collection is recorded on the appropriate case report forms. The data collected consist of: patient demographics (gender, race, age, weight), blood pressure readings, heart rate, coexisting comorbidities, concomitant chronic medications (generic name and dosage), indication and dose for trandolapril (Mavik®) and patient compliance. Laboratory values (microalbuminuria, estimated glomerular filtration rate) are only collected if the data are available for each patient. For baseline values (study Day 0), any laboratory value recorded within the past year prior to the baseline visit (Visit 1) is recorded, if the value is available. As per Canadian Hypertension Education Program recommendations and as a support and educational measure, patients are provided with (1) educational tools (nutrition guidebooks) and (2) home blood pressure monitoring devices. As per research and development guidelines, blood pressure devices were retrieved at the end of the study. Approximately 8,000 hypertensive participants were enrolled in the study at up to 700 sites across Canada. Sample size estimations were based on the assumption that 67.2% of non-diabetic hypertensive participants (assumed to make up to 69% of the eligible participant population) would reach a blood pressure target of <140/90mm Hg, while 22% of diabetes participants (31% of the eligible population) would meet a blood pressure target of <130/80 mm Hg with trandolapril (Mavik®) therapy.
Study Design
Study Type:
Observational
Actual Enrollment
:
7993 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Non-interventional, Observational Study To Describe the Effectiveness of Trandolapril (Mavik®) in the Management of Patients Requiring Angiotensin Converting Enzyme Inhibitor Treatment (In-MAU-tion)
Study Start Date
:
Dec 1, 2008
Actual Primary Completion Date
:
Sep 1, 2011
Actual Study Completion Date
:
Sep 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Hypertensive Participants Hypertensive diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction, who were naïve to trandolapril or on trandolapril within past 30 days. |
Outcome Measures
Primary Outcome Measures
- Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months [3 months]
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.
- Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months [6 months]
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.
- Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months [12 months]
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.
Secondary Outcome Measures
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months [Baseline, 3 Months]
Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg.
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months [Baseline, 6 Months]
Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg.
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months [Baseline,12 Months]
Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg.
- Change From Baseline in Microalbuminuria (MAU) at 3 Months [Baseline, 3 Months]
- Change From Baseline in Microalbuminuria (MAU) at 6 Months [Baseline, 6 Months]
- Change From Baseline in Microalbuminuria (MAU) at 12 Months [Baseline, 12 months]
- Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy [3 Months]
The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled."
- Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy [6 Months]
The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled."
- Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy [12 Months]
The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled."
- Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy [Day 0 (Baseline), 12 months]
Satisfaction with therapy at baseline (BL) and 12 months, using a 5-point Likert scale where participants responded to the question "Are you satisfied with your current hypertension therapy?". The range of responses varied from "1 = not at all satisfied" to "5 = extremely satisfied." Responses "2" through "4" were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively.
- Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy [Day 0 (Baseline), 12 months]
Satisfaction with therapy at baseline (BL) versus 12 months, using a 5-point Likert scale where participants responded to the question "Are you satisfied with your current hypertension therapy?". The range of responses varied from "1 = not at all satisfied" to "5 = extremely satisfied." Responses "2" through "4" were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively.
Other Outcome Measures
- Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy [3 Months]
Blood Pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
- Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy [6 Months]
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
- Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy [12 Months]
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
- Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy [3 Months]
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
- Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy [6 Months]
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
- Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy [12 Months]
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."
- Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months [Day 0 (Baseline), 3 Months]
- Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months [Day 0 (Baseline), 6 Months]
- Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months [Day 0 (Baseline), 12 Months]
- Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts [Day 0 (Baseline)]
- Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 [Day 0 (Baseline), Month 3]
- Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 [Day 0 (Baseline), Month 6]
- Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 [Day 0 (Baseline), Month 12]
- Number of Participants Compliant With Therapy After 3 Months [3 Months]
Compliance after 3 months of treatment was derived using responses to the Visit 2 question "How many trandolapril (Mavik®) doses have been missed since the subject's last visit?" If the response was "zero", the participant was classified as "compliant." If the response was any value greater than zero, regardless of the number of missed doses, the participant was classified as "non-compliant."
- Number of Participants Compliant With Therapy After 6 Months [6 Months]
Compliance after 6 months of treatment was derived using responses to the question "How many trandolapril (Mavik®) doses have been missed since the subject's last visit?" at both Visit 2 and Visit 3, as follows: If the response was "zero" at both the Visit 2 and Visit 3 assessments, participant was classified as "compliant" after 6 months of treatment; If the response was any value greater than zero at either of the Visit 2 or Visit 3 assessments, regardless of the number of missed doses, participant was classified as "non-compliant" after 6 months of treatment
- Number of Participants Compliant With Therapy After 12 Months [12 Months]
Compliance after 12 months of treatment was derived using responses to the question "How many trandolapril doses have been missed since the subject's last visit?" at Visit 2, Visit 3 and Visit 4, as follows: if the response was "zero" at all of the Visits 2 through 4 assessments, the participant was classified as "compliant" after 12 months of treatment; if the response was any value greater than zero at any of the Visits 2 through 4 assessments, regardless of the number of missed doses, the participant was classified as "non-compliant" after 12 months of treatment.
- Number of Participants With Dose Changes at 3 Months [3 Months]
- Number of Participants With Dose Changes at 6 Months [6 Months]
- Number of Participants With Dose Changes at 12 Months [12 Months]
- Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months [3 Months]
The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.
- Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months [6 Months]
The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.
- Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months [12 Months]
The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.
- Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months [3 Months]
Presented by type of medication added.
- Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months [6 Months]
Presented by type of medication added.
- Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months [12 Months]
Presented by type of medication added.
- Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months [3 Months]
Presented by type of medication discontinued.
- Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months [6 Months]
Presented by type of medication discontinued.
- Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months [12 Months]
Presented by type of medication discontinued.
- Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months [3 Months]
Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."
- Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months [6 Months]
Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."
- Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months [12 Months]
Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Adults capable of providing consent and who have uncontrolled hypertension
-
Participants were either treatment-naïve or had uncontrolled hypertension on their existing antihypertensive medication.
Exclusion Criteria:
- Participants were excluded from participation in the study if they had been taking trandolapril (Mavik®), alone or in combination, for more than 1 month prior to enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site Reference ID/Investigator# 32207 | Calgary | Alberta | Canada | T1Y 6H6 |
| 2 | Site Reference ID/Investigator# 10283 | Calgary | Alberta | Canada | T2E 2S9 |
| 3 | Site Reference ID/Investigator# 32168 | Calgary | Alberta | Canada | T2J 3N8 |
| 4 | Site Reference ID/Investigator# 32147 | Calgary | Alberta | Canada | T2M 0H5 |
| 5 | Site Reference ID/Investigator# 42438 | Calgary | Alberta | Canada | T2V 0M3 |
| 6 | Site Reference ID/Investigator# 32157 | Calgary | Alberta | Canada | T2V 1K2 |
| 7 | Site Reference ID/Investigator# 37940 | Calgary | Alberta | Canada | T2X 1P1 |
| 8 | Site Reference ID/Investigator# 32199 | Calgary | Alberta | Canada | T2X 3X7 |
| 9 | Site Reference ID/Investigator# 32144 | Calgary | Alberta | Canada | T3C 3P1 |
| 10 | Site Reference ID/Investigator# 32169 | Calgary | Alberta | Canada | T3E 5R7 |
| 11 | Site Reference ID/Investigator# 42391 | Edmonton | Alberta | Canada | T5C 3H7 |
| 12 | Site Reference ID/Investigator# 32146 | Edmonton | Alberta | Canada | T5K 0N8 |
| 13 | Site Reference ID/Investigator# 32165 | Edmonton | Alberta | Canada | T5T 2K6 |
| 14 | Site Reference ID/Investigator# 32197 | Edmonton | Alberta | Canada | T5T 2K6 |
| 15 | Site Reference ID/Investigator# 32126 | Edmonton | Alberta | Canada | T5T 4J5 |
| 16 | Site Reference ID/Investigator# 37892 | Edmonton | Alberta | Canada | T5T 5L4 |
| 17 | Site Reference ID/Investigator# 32178 | Edmonton | Alberta | Canada | T5T 5Y1 |
| 18 | Site Reference ID/Investigator# 42406 | Edmonton | Alberta | Canada | T5W 4W1 |
| 19 | Site Reference ID/Investigator# 32160 | Edmonton | Alberta | Canada | T5X 3N5 |
| 20 | Site Reference ID/Investigator# 32200 | Edmonton | Alberta | Canada | T5X 3N5 |
| 21 | Site Reference ID/Investigator# 32149 | Edmonton | Alberta | Canada | T6A 0A5 |
| 22 | Site Reference ID/Investigator# 32156 | Edmonton | Alberta | Canada | T6B 0P2 |
| 23 | Site Reference ID/Investigator# 32216 | Edmonton | Alberta | Canada | T6H 5B4 |
| 24 | Site Reference ID/Investigator# 32206 | Edmonton | Alberta | Canada | T6L 6N3 |
| 25 | Site Reference ID/Investigator# 32128 | Red Deer | Alberta | Canada | T4N 6V9 |
| 26 | Site Reference ID/Investigator# 32175 | Red Deer | Alberta | Canada | T4R 3J5 |
| 27 | Site Reference ID/Investigator# 32124 | Spruce Grove | Alberta | Canada | T7X 2V2 |
| 28 | Site Reference ID/Investigator# 30893 | Abbotsford | British Columbia | Canada | V2S 6R6 |
| 29 | Site Reference ID/Investigator# 37728 | Abbotsford | British Columbia | Canada | V2T 3S4 |
| 30 | Site Reference ID/Investigator# 31375 | Aldergrove | British Columbia | Canada | V4W 3L6 |
| 31 | Site Reference ID/Investigator# 30870 | Burnaby | British Columbia | Canada | V5C 5R4 |
| 32 | Site Reference ID/Investigator# 30964 | Burnaby | British Columbia | Canada | V5E 1E7 |
| 33 | Site Reference ID/Investigator# 31261 | Burnaby | British Columbia | Canada | V5H 2A9 |
| 34 | Site Reference ID/Investigator# 30946 | Burnaby | British Columbia | Canada | V5H 4J2 |
| 35 | Site Reference ID/Investigator# 30927 | Burnaby | British Columbia | Canada | V5H 4M4 |
| 36 | Site Reference ID/Investigator# 42433 | Coquitlam | British Columbia | Canada | V3B 6J6 |
| 37 | Site Reference ID/Investigator# 32213 | Coquitlam | British Columbia | Canada | V3B 6S2 |
| 38 | Site Reference ID/Investigator# 32166 | Delta | British Columbia | Canada | V4C 6R2 |
| 39 | Site Reference ID/Investigator# 31288 | Delta | British Columbia | Canada | V4C 6R4 |
| 40 | Site Reference ID/Investigator# 42404 | Delta | British Columbia | Canada | V4C 6R4 |
| 41 | Site Reference ID/Investigator# 37922 | Delta | British Columbia | Canada | V4E 2A6 |
| 42 | Site Reference ID/Investigator# 30926 | Delta | British Columbia | Canada | V4K 2K5 |
| 43 | Site Reference ID/Investigator# 37666 | Kamloops | British Columbia | Canada | V1S 1M9 |
| 44 | Site Reference ID/Investigator# 30929 | Kamloops | British Columbia | Canada | V2B 3G9 |
| 45 | Site Reference ID/Investigator# 32203 | Kamloops | British Columbia | Canada | V2C 5Y2 |
| 46 | Site Reference ID/Investigator# 37882 | Kamloops | British Columbia | Canada | V3B 3G2 |
| 47 | Site Reference ID/Investigator# 42365 | Kelowna | British Columbia | Canada | V1V 1A1 |
| 48 | Site Reference ID/Investigator# 33018 | Kelowna | British Columbia | Canada | V1X 7N6 |
| 49 | Site Reference ID/Investigator# 30915 | Kelowna | British Columbia | Canada | V1Y 8J8 |
| 50 | Site Reference ID/Investigator# 33043 | Langley | British Columbia | Canada | V3A 4G5 |
| 51 | Site Reference ID/Investigator# 31315 | Maple Ridge | British Columbia | Canada | V2X 6A4 |
| 52 | Site Reference ID/Investigator# 33234 | North Vancouver | British Columbia | Canada | V7M 2K2 |
| 53 | Site Reference ID/Investigator# 37846 | One Hundred Mile House | British Columbia | Canada | V0K 2E0 |
| 54 | Site Reference ID/Investigator# 32433 | Penticton | British Columbia | Canada | V2A 4M2 |
| 55 | Site Reference ID/Investigator# 32435 | Pitt Meadows | British Columbia | Canada | V3Y 2H6 |
| 56 | Site Reference ID/Investigator# 30884 | Port Coquitlam | British Columbia | Canada | V3B 6J3 |
| 57 | Site Reference ID/Investigator# 32467 | Richmond | British Columbia | Canada | K0A 2Z0 |
| 58 | Site Reference ID/Investigator# 37671 | Richmond | British Columbia | Canada | V6Y 3K5 |
| 59 | Site Reference ID/Investigator# 30890 | Surrey | British Columbia | Canada | V3R 3P1 |
| 60 | Site Reference ID/Investigator# 31278 | Surrey | British Columbia | Canada | V3R 6N7 |
| 61 | Site Reference ID/Investigator# 37888 | Surrey | British Columbia | Canada | V3S 2G2 |
| 62 | Site Reference ID/Investigator# 30966 | Surrey | British Columbia | Canada | V3T 2X6 |
| 63 | Site Reference ID/Investigator# 42332 | Surrey | British Columbia | Canada | V3V 6A8 |
| 64 | Site Reference ID/Investigator# 37780 | Surrey | British Columbia | Canada | V3V 6V9 |
| 65 | Site Reference ID/Investigator# 31383 | Surrey | British Columbia | Canada | V3W 3P2 |
| 66 | Site Reference ID/Investigator# 42422 | Surrey | British Columbia | Canada | V3W 3P2 |
| 67 | Site Reference ID/Investigator# 30867 | Trail | British Columbia | Canada | V1R 4T1 |
| 68 | Site Reference ID/Investigator# 30916 | Trail | British Columbia | Canada | V1R 4T1 |
| 69 | Site Reference ID/Investigator# 30908 | Vancouver | British Columbia | Canada | V5N 5K4 |
| 70 | Site Reference ID/Investigator# 33122 | Vancouver | British Columbia | Canada | V5N 5K4 |
| 71 | Site Reference ID/Investigator# 31396 | Vancouver | British Columbia | Canada | V5P 3Y2 |
| 72 | Site Reference ID/Investigator# 30919 | Vancouver | British Columbia | Canada | V5V 3P1 |
| 73 | Site Reference ID/Investigator# 37725 | Vancouver | British Columbia | Canada | V5W 2Z7 |
| 74 | Site Reference ID/Investigator# 33123 | Vancouver | British Columbia | Canada | V5Z 2M9 |
| 75 | Site Reference ID/Investigator# 37771 | Vancouver | British Columbia | Canada | V5Z 4E1 |
| 76 | Site Reference ID/Investigator# 31316 | Victoria | British Columbia | Canada | V8N 1A4 |
| 77 | Site Reference ID/Investigator# 31277 | Victoria | British Columbia | Canada | V8R 6T9 |
| 78 | Site Reference ID/Investigator# 32177 | Victoria | British Columbia | Canada | V8T 5G1 |
| 79 | Site Reference ID/Investigator# 33128 | Victoria | British Columbia | Canada | V8V 3N7 |
| 80 | Site Reference ID/Investigator# 33129 | Victoria | British Columbia | Canada | V8V 4A1 |
| 81 | Site Reference ID/Investigator# 30938 | Victoria | British Columbia | Canada | V8X 4V1 |
| 82 | Site Reference ID/Investigator# 32120 | Victoria | British Columbia | Canada | V9A 1B7 |
| 83 | Site Reference ID/Investigator# 30952 | Victoria | British Columbia | Canada | V9A 3N7 |
| 84 | Site Reference ID/Investigator# 31320 | Victoria | British Columbia | Canada | V9A 7N6 |
| 85 | Site Reference ID/Investigator# 32191 | West Vancouver | British Columbia | Canada | V7V 1J6 |
| 86 | Site Reference ID/Investigator# 30951 | Whitby | British Columbia | Canada | L1N 8M7 |
| 87 | Site Reference ID/Investigator# 32227 | Brandon | Manitoba | Canada | R7A 0B9 |
| 88 | Site Reference ID/Investigator# 30933 | Gimli | Manitoba | Canada | R0C 1B0 |
| 89 | Site Reference ID/Investigator# 31328 | Stonewall | Manitoba | Canada | R0C 2Z0 |
| 90 | Site Reference ID/Investigator# 31376 | Stonewall | Manitoba | Canada | R0C 2Z0 |
| 91 | Site Reference ID/Investigator# 31306 | Winnipeg | Manitoba | Canada | R2C 1R2 |
| 92 | Site Reference ID/Investigator# 31395 | Winnipeg | Manitoba | Canada | R2C 1R2 |
| 93 | Site Reference ID/Investigator# 33169 | Winnipeg | Manitoba | Canada | R2H 0R8 |
| 94 | Site Reference ID/Investigator# 33167 | Winnipeg | Manitoba | Canada | R2H 0W1 |
| 95 | Site Reference ID/Investigator# 32180 | Winnipeg | Manitoba | Canada | R2M 3T2 |
| 96 | Site Reference ID/Investigator# 30901 | Winnipeg | Manitoba | Canada | R2V 3C4 |
| 97 | Site Reference ID/Investigator# 33173 | Winnipeg | Manitoba | Canada | R2V 3N7 |
| 98 | Site Reference ID/Investigator# 33171 | Winnipeg | Manitoba | Canada | R2W 3P4 |
| 99 | Site Reference ID/Investigator# 32122 | Winnipeg | Manitoba | Canada | R3A 1M3 |
| 100 | Site Reference ID/Investigator# 33172 | Winnipeg | Manitoba | Canada | R3C 0N2 |
| 101 | Site Reference ID/Investigator# 33174 | Winnipeg | Manitoba | Canada | R3C 2B3 |
| 102 | Site Reference ID/Investigator# 33166 | Winnipeg | Manitoba | Canada | R3J 0S9 |
| 103 | Site Reference ID/Investigator# 31263 | Winnipeg | Manitoba | Canada | R3Y 1L6 |
| 104 | Site Reference ID/Investigator# 32209 | Dieppe | New Brunswick | Canada | E1A 1N5 |
| 105 | Site Reference ID/Investigator# 32212 | Moncton | New Brunswick | Canada | E1C 1X6 |
| 106 | Site Reference ID/Investigator# 32211 | St Louis De Kent | New Brunswick | Canada | E4X 1E7 |
| 107 | Site Reference ID/Investigator# 31322 | Sussex | New Brunswick | Canada | E4E 2P1 |
| 108 | Site Reference ID/Investigator# 30878 | Conception Bay South | Newfoundland and Labrador | Canada | A1W 3A6 |
| 109 | Site Reference ID/Investigator# 30957 | Marystown | Newfoundland and Labrador | Canada | A0E 2M0 |
| 110 | Site Reference ID/Investigator# 33094 | Marystown | Newfoundland and Labrador | Canada | A0E 2M0 |
| 111 | Site Reference ID/Investigator# 32154 | Mount Pearl | Newfoundland and Labrador | Canada | A1N 5K8 |
| 112 | Site Reference ID/Investigator# 33193 | Mount Pearl | Newfoundland and Labrador | Canada | A1N 5K8 |
| 113 | Site Reference ID/Investigator# 30892 | St John's | Newfoundland and Labrador | Canada | A1A 5E8 |
| 114 | Site Reference ID/Investigator# 30936 | St. John's | Newfoundland and Labrador | Canada | A1E 2Z3 |
| 115 | Site Reference ID/Investigator# 31314 | Bridgewater | Nova Scotia | Canada | B4V 2V6 |
| 116 | Site Reference ID/Investigator# 31276 | Bridgewater | Nova Scotia | Canada | B4V 3N2 |
| 117 | Site Reference ID/Investigator# 31264 | Dartmouth | Nova Scotia | Canada | B2W 3E5 |
| 118 | Site Reference ID/Investigator# 31321 | Dartmouth | Nova Scotia | Canada | B2W 3E5 |
| 119 | Site Reference ID/Investigator# 31327 | Halifax | Nova Scotia | Canada | B3H 2Y1 |
| 120 | Site Reference ID/Investigator# 37781 | Kentville | Nova Scotia | Canada | B4N 1M6 |
| 121 | Site Reference ID/Investigator# 33072 | Lower Sackville | Nova Scotia | Canada | B4C 2N1 |
| 122 | Site Reference ID/Investigator# 30894 | Lower Sackville | Nova Scotia | Canada | B4C 2R3 |
| 123 | Site Reference ID/Investigator# 42461 | Middleton | Nova Scotia | Canada | B0S 1P0 |
| 124 | Site Reference ID/Investigator# 32508 | Sheet Harbour | Nova Scotia | Canada | B0J 3B0 |
| 125 | Site Reference ID/Investigator# 31352 | Shubencadie | Nova Scotia | Canada | B0N 2H0 |
| 126 | Site Reference ID/Investigator# 42403 | Truro | Nova Scotia | Canada | B2N 5A4 |
| 127 | Site Reference ID/Investigator# 33165 | Windsor | Nova Scotia | Canada | B0N 2T0 |
| 128 | Site Reference ID/Investigator# 42367 | Ajax | Ontario | Canada | L1S 7K8 |
| 129 | Site Reference ID/Investigator# 42464 | Ameherstburg | Ontario | Canada | N9V 0B4 |
| 130 | Site Reference ID/Investigator# 37885 | Amherstview | Ontario | Canada | K7N 1S3 |
| 131 | Site Reference ID/Investigator# 42409 | Aurora | Ontario | Canada | L4G 7Y3 |
| 132 | Site Reference ID/Investigator# 42449 | Aurora | Ontario | Canada | L4G 7Y3 |
| 133 | Site Reference ID/Investigator# 30943 | Aurora | Ontario | Canada | L4G 7Z9 |
| 134 | Site Reference ID/Investigator# 30963 | Barrie | Ontario | Canada | L4N 6M2 |
| 135 | Site Reference ID/Investigator# 30954 | Belleville | Ontario | Canada | K8N 5G8 |
| 136 | Site Reference ID/Investigator# 30879 | Belleville | Ontario | Canada | K8P 5E2 |
| 137 | Site Reference ID/Investigator# 42378 | Bolton | Ontario | Canada | L7E 4C8 |
| 138 | Site Reference ID/Investigator# 30888 | Bowmanville | Ontario | Canada | L1C 1P3 |
| 139 | Site Reference ID/Investigator# 30947 | Bowmanville | Ontario | Canada | L1C 1P6 |
| 140 | Site Reference ID/Investigator# 31286 | Bradford | Ontario | Canada | L3Z 2B6 |
| 141 | Site Reference ID/Investigator# 32192 | Bradford | Ontario | Canada | L3Z 2B8 |
| 142 | Site Reference ID/Investigator# 37911 | Brampton | Ontario | Canada | L6R 3J5 |
| 143 | Site Reference ID/Investigator# 37932 | Brampton | Ontario | Canada | L6T 3R5 |
| 144 | Site Reference ID/Investigator# 30882 | Brampton | Ontario | Canada | L6X 5E9 |
| 145 | Site Reference ID/Investigator# 37929 | Brampton | Ontario | Canada | L7A 3E5 |
| 146 | Site Reference ID/Investigator# 37768 | Brantford | Ontario | Canada | N3T 5Z8 |
| 147 | Site Reference ID/Investigator# 37934 | Burlington | Ontario | Canada | L7L 0B7 |
| 148 | Site Reference ID/Investigator# 32173 | Burlington | Ontario | Canada | L7M 4Y1 |
| 149 | Site Reference ID/Investigator# 32210 | Burlington | Ontario | Canada | L7R 1E2 |
| 150 | Site Reference ID/Investigator# 37919 | Burlington | Ontario | Canada | L7R 2H3 |
| 151 | Site Reference ID/Investigator# 31359 | Burlington | Ontario | Canada | L7R 2H7 |
| 152 | Site Reference ID/Investigator# 37923 | Burlington | Ontario | Canada | L7R 2H7 |
| 153 | Site Reference ID/Investigator# 37845 | Burlington | Ontario | Canada | L7R 4H9 |
| 154 | Site Reference ID/Investigator# 47571 | Collingwood | Ontario | Canada | L9Y 1W6 |
| 155 | Site Reference ID/Investigator# 30956 | Cornwall | Ontario | Canada | K6H 4A2 |
| 156 | Site Reference ID/Investigator# 30969 | Corunna | Ontario | Canada | N0N 1G0 |
| 157 | Site Reference ID/Investigator# 30961 | Dashwood | Ontario | Canada | N0M 1N0 |
| 158 | Site Reference ID/Investigator# 37850 | Dolbeau-Mistassini | Ontario | Canada | G8L 5J8 |
| 159 | Site Reference ID/Investigator# 42389 | Durham | Ontario | Canada | N0G 1R0 |
| 160 | Site Reference ID/Investigator# 42385 | East York | Ontario | Canada | M4B 2S7 |
| 161 | Site Reference ID/Investigator# 42397 | East York | Ontario | Canada | M4C 5M1 |
| 162 | Site Reference ID/Investigator# 42400 | East York | Ontario | Canada | M4C 5M1 |
| 163 | Site Reference ID/Investigator# 42423 | East York | Ontario | Canada | M4C 5M1 |
| 164 | Site Reference ID/Investigator# 30930 | East York | Ontario | Canada | M4C 5T2 |
| 165 | Site Reference ID/Investigator# 31363 | East York | Ontario | Canada | M4K 3V9 |
| 166 | Site Reference ID/Investigator# 42342 | Elmvale | Ontario | Canada | L0L 1P0 |
| 167 | Site Reference ID/Investigator# 32873 | Etobicoke | Ontario | Canada | M8V 3X8 |
| 168 | Site Reference ID/Investigator# 31353 | Etobicoke | Ontario | Canada | M8W 3W2 |
| 169 | Site Reference ID/Investigator# 37774 | Etobicoke | Ontario | Canada | M8X 1E2 |
| 170 | Site Reference ID/Investigator# 32871 | Etobicoke | Ontario | Canada | M9B 3Z9 |
| 171 | Site Reference ID/Investigator# 32870 | Etobicoke | Ontario | Canada | M9V 5G4 |
| 172 | Site Reference ID/Investigator# 32872 | Etobicoke | Ontario | Canada | M9V 5G4 |
| 173 | Site Reference ID/Investigator# 32880 | Fonthill | Ontario | Canada | L0S 1E0 |
| 174 | Site Reference ID/Investigator# 30873 | Fort Erie | Ontario | Canada | L2A 1Z3 |
| 175 | Site Reference ID/Investigator# 31310 | Fort Erie | Ontario | Canada | L2A 1Z3 |
| 176 | Site Reference ID/Investigator# 31356 | Fort Erie | Ontario | Canada | L2A 6E2 |
| 177 | Site Reference ID/Investigator# 31367 | Georgetown | Ontario | Canada | L7G 5E9 |
| 178 | Site Reference ID/Investigator# 31381 | Georgetown | Ontario | Canada | L7G 5G1 |
| 179 | Site Reference ID/Investigator# 30965 | Grimsby | Ontario | Canada | L3M 1P1 |
| 180 | Site Reference ID/Investigator# 31285 | Grimsby | Ontario | Canada | L3M 1P3 |
| 181 | Site Reference ID/Investigator# 42347 | Guelph | Ontario | Canada | N1E 6L9 |
| 182 | Site Reference ID/Investigator# 42462 | Guelph | Ontario | Canada | N1H 5J1 |
| 183 | Site Reference ID/Investigator# 31282 | Hamilton | Ontario | Canada | L8H 4R6 |
| 184 | Site Reference ID/Investigator# 32223 | Hamilton | Ontario | Canada | L8J 0B6 |
| 185 | Site Reference ID/Investigator# 42440 | Hamilton | Ontario | Canada | L8J 2N5 |
| 186 | Site Reference ID/Investigator# 32214 | Hamilton | Ontario | Canada | L8K 3P3 |
| 187 | Site Reference ID/Investigator# 30924 | Hamilton | Ontario | Canada | L8L 5G8 |
| 188 | Site Reference ID/Investigator# 31348 | Hamilton | Ontario | Canada | L8L 5G8 |
| 189 | Site Reference ID/Investigator# 30940 | Hamilton | Ontario | Canada | L8S 1C5 |
| 190 | Site Reference ID/Investigator# 37907 | Hamilton | Ontario | Canada | L8S 1E7 |
| 191 | Site Reference ID/Investigator# 31389 | Hamilton | Ontario | Canada | L9A 2G7 |
| 192 | Site Reference ID/Investigator# 31275 | Hamilton | Ontario | Canada | L9A 5H4 |
| 193 | Site Reference ID/Investigator# 32965 | Hawkesbury | Ontario | Canada | K6A 2R2 |
| 194 | Site Reference ID/Investigator# 31373 | Hawkesbury | Ontario | Canada | K6A 3B2 |
| 195 | Site Reference ID/Investigator# 33002 | Jarvis | Ontario | Canada | N0A 1J0 |
| 196 | Site Reference ID/Investigator# 30876 | Jordan Station | Ontario | Canada | L0R 1S0 |
| 197 | Site Reference ID/Investigator# 32611 | Keswick | Ontario | Canada | L4P 0A9 |
| 198 | Site Reference ID/Investigator# 33020 | Keswick | Ontario | Canada | L4P 2C7 |
| 199 | Site Reference ID/Investigator# 31386 | Kirkfield | Ontario | Canada | K0M 2B0 |
| 200 | Site Reference ID/Investigator# 42443 | Kitchener | Ontario | Canada | N2G 1E3 |
| 201 | Site Reference ID/Investigator# 30895 | Kitchener | Ontario | Canada | N2G 4V4 |
| 202 | Site Reference ID/Investigator# 37783 | Kitchener | Ontario | Canada | N2G 4V5 |
| 203 | Site Reference ID/Investigator# 37906 | Kitchener | Ontario | Canada | N2M 5N6 |
| 204 | Site Reference ID/Investigator# 42467 | Kitchener | Ontario | Canada | N2N 2A8 |
| 205 | Site Reference ID/Investigator# 32174 | La Salle | Ontario | Canada | N9J 2C1 |
| 206 | Site Reference ID/Investigator# 37910 | La Salle | Ontario | Canada | N9J 2C1 |
| 207 | Site Reference ID/Investigator# 31347 | Lasalle | Ontario | Canada | H8N 1X9 |
| 208 | Site Reference ID/Investigator# 32220 | Lindsay | Ontario | Canada | K9V 5N7 |
| 209 | Site Reference ID/Investigator# 42348 | Lindsay | Ontario | Canada | K9V 6C5 |
| 210 | Site Reference ID/Investigator# 32196 | London | Ontario | Canada | N5V 2E3 |
| 211 | Site Reference ID/Investigator# 30900 | London | Ontario | Canada | N5Y 3H9 |
| 212 | Site Reference ID/Investigator# 33070 | London | Ontario | Canada | N6A 5G9 |
| 213 | Site Reference ID/Investigator# 31333 | London | Ontario | Canada | N6C 4Y7 |
| 214 | Site Reference ID/Investigator# 32148 | London | Ontario | Canada | N6E 3B9 |
| 215 | Site Reference ID/Investigator# 31340 | London | Ontario | Canada | N6J 1Y4 |
| 216 | Site Reference ID/Investigator# 31385 | Markham | Ontario | Canada | L3P 5T7 |
| 217 | Site Reference ID/Investigator# 33091 | Markham | Ontario | Canada | L3S 1R7 |
| 218 | Site Reference ID/Investigator# 33090 | Markham | Ontario | Canada | L3S 3K9 |
| 219 | Site Reference ID/Investigator# 42337 | Markham | Ontario | Canada | L6B 0P9 |
| 220 | Site Reference ID/Investigator# 30967 | Milton | Ontario | Canada | L9T 6R2 |
| 221 | Site Reference ID/Investigator# 33104 | Mississauga | Ontario | Canada | L4T 4E3 |
| 222 | Site Reference ID/Investigator# 42398 | Mississauga | Ontario | Canada | L4X 2Z9 |
| 223 | Site Reference ID/Investigator# 33106 | Mississauga | Ontario | Canada | L4Y 2A6 |
| 224 | Site Reference ID/Investigator# 30945 | Mississauga | Ontario | Canada | L5A 1W4 |
| 225 | Site Reference ID/Investigator# 33105 | Mississauga | Ontario | Canada | L5B 3A8 |
| 226 | Site Reference ID/Investigator# 37673 | Mississauga | Ontario | Canada | L5B 4M4 |
| 227 | Site Reference ID/Investigator# 42331 | Mississauga | Ontario | Canada | L5B 4M4 |
| 228 | Site Reference ID/Investigator# 42373 | Mississauga | Ontario | Canada | L5C 2R9 |
| 229 | Site Reference ID/Investigator# 42468 | Mississauga | Ontario | Canada | L5C 2R9 |
| 230 | Site Reference ID/Investigator# 32152 | Mississauga | Ontario | Canada | L5N 2W7 |
| 231 | Site Reference ID/Investigator# 37723 | Mississauga | Ontario | Canada | L5N 4H4 |
| 232 | Site Reference ID/Investigator# 37903 | Mississauga | Ontario | Canada | L5N 6S3 |
| 233 | Site Reference ID/Investigator# 37904 | Mississauga | Ontario | Canada | L5N 6S3 |
| 234 | Site Reference ID/Investigator# 31312 | Mississauga | Ontario | Canada | L5R 4B8 |
| 235 | Site Reference ID/Investigator# 42327 | Nepean | Ontario | Canada | K2G 1W2 |
| 236 | Site Reference ID/Investigator# 31364 | Nepean | Ontario | Canada | K2H 9A5 |
| 237 | Site Reference ID/Investigator# 31334 | Nepean | Ontario | Canada | K2J 3Z6 |
| 238 | Site Reference ID/Investigator# 31357 | Newboro | Ontario | Canada | K0G 1P0 |
| 239 | Site Reference ID/Investigator# 42445 | Newcastle | Ontario | Canada | L1B 1H8 |
| 240 | Site Reference ID/Investigator# 37770 | Newmarket | Ontario | Canada | L3Y 2N1 |
| 241 | Site Reference ID/Investigator# 30970 | Newmarket | Ontario | Canada | L3Y 5G8 |
| 242 | Site Reference ID/Investigator# 31388 | Newmarket | Ontario | Canada | L3Y 5G8 |
| 243 | Site Reference ID/Investigator# 37930 | Newmarket | Ontario | Canada | L3Y 7V1 |
| 244 | Site Reference ID/Investigator# 32172 | Niagara Falls | Ontario | Canada | L2G 6B9 |
| 245 | Site Reference ID/Investigator# 31326 | North Bay | Ontario | Canada | P1B 0A7 |
| 246 | Site Reference ID/Investigator# 30913 | North Bay | Ontario | Canada | P1B 8G1 |
| 247 | Site Reference ID/Investigator# 30937 | North York | Ontario | Canada | M2J 2Z1 |
| 248 | Site Reference ID/Investigator# 32601 | North York | Ontario | Canada | M2N 7J5 |
| 249 | Site Reference ID/Investigator# 32602 | North York | Ontario | Canada | M2N 7J5 |
| 250 | Site Reference ID/Investigator# 42442 | North York | Ontario | Canada | M3B 2W7 |
| 251 | Site Reference ID/Investigator# 30896 | North York | Ontario | Canada | M3C 1T2 |
| 252 | Site Reference ID/Investigator# 31265 | North York | Ontario | Canada | M3C 1T2 |
| 253 | Site Reference ID/Investigator# 32607 | North York | Ontario | Canada | M3J 1N2 |
| 254 | Site Reference ID/Investigator# 42407 | North York | Ontario | Canada | M3N 2K1 |
| 255 | Site Reference ID/Investigator# 42435 | North York | Ontario | Canada | M3N 2Z9 |
| 256 | Site Reference ID/Investigator# 33235 | North York | Ontario | Canada | M9N 1X2 |
| 257 | Site Reference ID/Investigator# 31350 | Oakville | Ontario | Canada | L6H 3P1 |
| 258 | Site Reference ID/Investigator# 37842 | Oakville | Ontario | Canada | L6H 3P1 |
| 259 | Site Reference ID/Investigator# 30910 | Oshawa | Ontario | Canada | L1H 1B9 |
| 260 | Site Reference ID/Investigator# 30971 | Oshawa | Ontario | Canada | L1H 1B9 |
| 261 | Site Reference ID/Investigator# 42459 | Oshawa | Ontario | Canada | L1H 1B9 |
| 262 | Site Reference ID/Investigator# 42415 | Oshawa | Ontario | Canada | L1H 1G4 |
| 263 | Site Reference ID/Investigator# 32162 | Oshawa | Ontario | Canada | L1H 7K4 |
| 264 | Site Reference ID/Investigator# 33260 | Oshawa | Ontario | Canada | L1H 7K4 |
| 265 | Site Reference ID/Investigator# 42363 | Oshawa | Ontario | Canada | L1H 7K4 |
| 266 | Site Reference ID/Investigator# 32164 | Oshawa | Ontario | Canada | L1J 2K1 |
| 267 | Site Reference ID/Investigator# 32185 | Ottawa | Ontario | Canada | K1H 1A2 |
| 268 | Site Reference ID/Investigator# 37884 | Ottawa | Ontario | Canada | K1H 1A2 |
| 269 | Site Reference ID/Investigator# 32422 | Ottawa | Ontario | Canada | K1K 4L2 |
| 270 | Site Reference ID/Investigator# 33267 | Ottawa | Ontario | Canada | K1L 8M3 |
| 271 | Site Reference ID/Investigator# 42425 | Ottawa | Ontario | Canada | K1Z 7K8 |
| 272 | Site Reference ID/Investigator# 32190 | Ottawa | Ontario | Canada | K2A 3V5 |
| 273 | Site Reference ID/Investigator# 31380 | Ottawa | Ontario | Canada | K2B 7Z2 |
| 274 | Site Reference ID/Investigator# 31287 | Ottawa | Ontario | Canada | K2C 0C7 |
| 275 | Site Reference ID/Investigator# 33266 | Ottawa | Ontario | Canada | K2C 0C7 |
| 276 | Site Reference ID/Investigator# 31301 | Ottawa | Ontario | Canada | K2G 3Y5 |
| 277 | Site Reference ID/Investigator# 37785 | Owen Sound | Ontario | Canada | N4K 2K9 |
| 278 | Site Reference ID/Investigator# 42351 | Pickering | Ontario | Canada | L1V 1A6 |
| 279 | Site Reference ID/Investigator# 42417 | Pickering | Ontario | Canada | L1V 1C1 |
| 280 | Site Reference ID/Investigator# 42418 | Pickering | Ontario | Canada | L1V 1C1 |
| 281 | Site Reference ID/Investigator# 42419 | Pickering | Ontario | Canada | L1V 1C1 |
| 282 | Site Reference ID/Investigator# 37848 | Pickering | Ontario | Canada | L1V 4G6 |
| 283 | Site Reference ID/Investigator# 42434 | Pickering | Ontario | Canada | L1W 1S7 |
| 284 | Site Reference ID/Investigator# 32184 | Richmond Hill | Ontario | Canada | L4C 1G6 |
| 285 | Site Reference ID/Investigator# 32224 | Richmond Hill | Ontario | Canada | L4C 1T5 |
| 286 | Site Reference ID/Investigator# 30932 | Richmond Hill | Ontario | Canada | L4C 2N9 |
| 287 | Site Reference ID/Investigator# 31270 | Richmond Hill | Ontario | Canada | L4C 2N9 |
| 288 | Site Reference ID/Investigator# 30872 | Richmond Hill | Ontario | Canada | L4C 5G2 |
| 289 | Site Reference ID/Investigator# 32466 | Richmond | Ontario | Canada | V6X 1A1 |
| 290 | Site Reference ID/Investigator# 32468 | Richmond | Ontario | Canada | V6X 3Z9 |
| 291 | Site Reference ID/Investigator# 37664 | Sarnia | Ontario | Canada | N7T 4X3 |
| 292 | Site Reference ID/Investigator# 37759 | Sault Ste Marie | Ontario | Canada | P6A 2C5 |
| 293 | Site Reference ID/Investigator# 37772 | Sault Ste Marie | Ontario | Canada | P6C 2J4 |
| 294 | Site Reference ID/Investigator# 42469 | Scarborough | Ontario | Canada | M1B 2W4 |
| 295 | Site Reference ID/Investigator# 37895 | Scarborough | Ontario | Canada | M1C 3B2 |
| 296 | Site Reference ID/Investigator# 42457 | Scarborough | Ontario | Canada | M1C 3B2 |
| 297 | Site Reference ID/Investigator# 30942 | Scarborough | Ontario | Canada | M1G 1P4 |
| 298 | Site Reference ID/Investigator# 37739 | Scarborough | Ontario | Canada | M1H 1B7 |
| 299 | Site Reference ID/Investigator# 30912 | Scarborough | Ontario | Canada | M1H 3G4 |
| 300 | Site Reference ID/Investigator# 32495 | Scarborough | Ontario | Canada | M1H 3G4 |
| 301 | Site Reference ID/Investigator# 42421 | Scarborough | Ontario | Canada | M1J 2H6 |
| 302 | Site Reference ID/Investigator# 42441 | Scarborough | Ontario | Canada | M1K 2M2 |
| 303 | Site Reference ID/Investigator# 31346 | Scarborough | Ontario | Canada | M1K 2S3 |
| 304 | Site Reference ID/Investigator# 37890 | Scarborough | Ontario | Canada | M1P 2S1 |
| 305 | Site Reference ID/Investigator# 30906 | Scarborough | Ontario | Canada | M1P 2T4 |
| 306 | Site Reference ID/Investigator# 42439 | Scarborough | Ontario | Canada | M1R 3A6 |
| 307 | Site Reference ID/Investigator# 31305 | Scarborough | Ontario | Canada | M1S 1S7 |
| 308 | Site Reference ID/Investigator# 42410 | Scarborough | Ontario | Canada | M1S 1S7 |
| 309 | Site Reference ID/Investigator# 30958 | Scarborough | Ontario | Canada | M1S 1T7 |
| 310 | Site Reference ID/Investigator# 42369 | Scarborough | Ontario | Canada | M1S 4NG |
| 311 | Site Reference ID/Investigator# 30939 | Scarborough | Ontario | Canada | M1S 4T7 |
| 312 | Site Reference ID/Investigator# 30960 | Scarborough | Ontario | Canada | M1S 4T7 |
| 313 | Site Reference ID/Investigator# 31382 | Scarborough | Ontario | Canada | M1S 4T7 |
| 314 | Site Reference ID/Investigator# 47576 | Scarborough | Ontario | Canada | M1S 4T7 |
| 315 | Site Reference ID/Investigator# 37916 | Scarborough | Ontario | Canada | M1V 5J6 |
| 316 | Site Reference ID/Investigator# 31296 | Scarborough | Ontario | Canada | M1V 5P6 |
| 317 | Site Reference ID/Investigator# 32494 | Scarborough | Ontario | Canada | M1W 2S8 |
| 318 | Site Reference ID/Investigator# 42408 | Scarborough | Ontario | Canada | M1W 2T4 |
| 319 | Site Reference ID/Investigator# 32219 | Schomberg | Ontario | Canada | L0G 1T0 |
| 320 | Site Reference ID/Investigator# 42325 | Smiths Falls | Ontario | Canada | K7A 3Y3 |
| 321 | Site Reference ID/Investigator# 31365 | Smiths Falls | Ontario | Canada | K7A 4W8 |
| 322 | Site Reference ID/Investigator# 32514 | Southampton | Ontario | Canada | N0H 2L0 |
| 323 | Site Reference ID/Investigator# 37777 | St. Catharines | Ontario | Canada | L2M 2Z9 |
| 324 | Site Reference ID/Investigator# 37668 | St. Catherines | Ontario | Canada | L2R 5K3 |
| 325 | Site Reference ID/Investigator# 32171 | St. Catherines | Ontario | Canada | L2R 7P3 |
| 326 | Site Reference ID/Investigator# 32201 | Stirling | Ontario | Canada | K0K 3E0 |
| 327 | Site Reference ID/Investigator# 42387 | Stirling | Ontario | Canada | K0K 3E0 |
| 328 | Site Reference ID/Investigator# 42333 | Stoney Creek | Ontario | Canada | L8G 2C5 |
| 329 | Site Reference ID/Investigator# 32181 | Stoney Creek | Ontario | Canada | L8G 3L2 |
| 330 | Site Reference ID/Investigator# 37672 | Sudbury | Ontario | Canada | L5B 6C3 |
| 331 | Site Reference ID/Investigator# 37674 | Sudbury | Ontario | Canada | P3A 1Y8 |
| 332 | Site Reference ID/Investigator# 31271 | Sudbury | Ontario | Canada | P3E 1A9 |
| 333 | Site Reference ID/Investigator# 37784 | Sudbury | Ontario | Canada | P3E 1B8 |
| 334 | Site Reference ID/Investigator# 32529 | Sudbury | Ontario | Canada | P3E 3C6 |
| 335 | Site Reference ID/Investigator# 37889 | Surrey | Ontario | Canada | V3W 2M9 |
| 336 | Site Reference ID/Investigator# 37662 | Tecumseh | Ontario | Canada | N8N 1M2 |
| 337 | Site Reference ID/Investigator# 37663 | Tecumseh | Ontario | Canada | N8N 1M2 |
| 338 | Site Reference ID/Investigator# 42392 | Thornbury | Ontario | Canada | N0H 2P0 |
| 339 | Site Reference ID/Investigator# 32536 | Thornhill | Ontario | Canada | L4J 2J6 |
| 340 | Site Reference ID/Investigator# 31300 | Thunder Bay | Ontario | Canada | P7E 5H7 |
| 341 | Site Reference ID/Investigator# 37938 | Thunder Bay | Ontario | Canada | P7E 5H7 |
| 342 | Site Reference ID/Investigator# 37787 | Timmins | Ontario | Canada | P4N 1G2 |
| 343 | Site Reference ID/Investigator# 37913 | Timmins | Ontario | Canada | P4N 6K6 |
| 344 | Site Reference ID/Investigator# 32539 | Toronto | Ontario | Canada | M1W 2S1 |
| 345 | Site Reference ID/Investigator# 32548 | Toronto | Ontario | Canada | M2N 1C8 |
| 346 | Site Reference ID/Investigator# 33044 | Toronto | Ontario | Canada | M3H 3P4 |
| 347 | Site Reference ID/Investigator# 42350 | Toronto | Ontario | Canada | M4C 3B7 |
| 348 | Site Reference ID/Investigator# 42446 | Toronto | Ontario | Canada | M4C 5M1 |
| 349 | Site Reference ID/Investigator# 32544 | Toronto | Ontario | Canada | M4J 1N4 |
| 350 | Site Reference ID/Investigator# 30920 | Toronto | Ontario | Canada | M4J 1N5 |
| 351 | Site Reference ID/Investigator# 32546 | Toronto | Ontario | Canada | M4K 1N2 |
| 352 | Site Reference ID/Investigator# 42381 | Toronto | Ontario | Canada | M4K 2P8 |
| 353 | Site Reference ID/Investigator# 32121 | Toronto | Ontario | Canada | M4L 3B5 |
| 354 | Site Reference ID/Investigator# 31269 | Toronto | Ontario | Canada | M4M 1J5 |
| 355 | Site Reference ID/Investigator# 30925 | Toronto | Ontario | Canada | M4M 1Y2 |
| 356 | Site Reference ID/Investigator# 37853 | Toronto | Ontario | Canada | M4M 1Y2 |
| 357 | Site Reference ID/Investigator# 31354 | Toronto | Ontario | Canada | M4P 1P2 |
| 358 | Site Reference ID/Investigator# 32542 | Toronto | Ontario | Canada | M4V 1R3 |
| 359 | Site Reference ID/Investigator# 37931 | Toronto | Ontario | Canada | M4X 1P9 |
| 360 | Site Reference ID/Investigator# 32125 | Toronto | Ontario | Canada | M4X 1W4 |
| 361 | Site Reference ID/Investigator# 42376 | Toronto | Ontario | Canada | M5G 1N8 |
| 362 | Site Reference ID/Investigator# 32549 | Toronto | Ontario | Canada | M5R 3M8 |
| 363 | Site Reference ID/Investigator# 32540 | Toronto | Ontario | Canada | M5R 3MB |
| 364 | Site Reference ID/Investigator# 32538 | Toronto | Ontario | Canada | M5T 1G9 |
| 365 | Site Reference ID/Investigator# 37933 | Toronto | Ontario | Canada | M5T 2E7 |
| 366 | Site Reference ID/Investigator# 30874 | Toronto | Ontario | Canada | M5T 2G3 |
| 367 | Site Reference ID/Investigator# 31274 | Toronto | Ontario | Canada | M5T 2G3 |
| 368 | Site Reference ID/Investigator# 37936 | Toronto | Ontario | Canada | M5V 2A9 |
| 369 | Site Reference ID/Investigator# 42436 | Toronto | Ontario | Canada | M5V 2A9 |
| 370 | Site Reference ID/Investigator# 42370 | Toronto | Ontario | Canada | M6B 4J3 |
| 371 | Site Reference ID/Investigator# 30948 | Toronto | Ontario | Canada | M6C 1A3 |
| 372 | Site Reference ID/Investigator# 31336 | Toronto | Ontario | Canada | M6C 1A3 |
| 373 | Site Reference ID/Investigator# 32541 | Toronto | Ontario | Canada | M6E 1B5 |
| 374 | Site Reference ID/Investigator# 37786 | Toronto | Ontario | Canada | M6E 1B5 |
| 375 | Site Reference ID/Investigator# 31295 | Toronto | Ontario | Canada | M6G 1A4 |
| 376 | Site Reference ID/Investigator# 31391 | Toronto | Ontario | Canada | M6G 1A4 |
| 377 | Site Reference ID/Investigator# 37925 | Toronto | Ontario | Canada | M6G 1A4 |
| 378 | Site Reference ID/Investigator# 30953 | Toronto | Ontario | Canada | M6G 1A6 |
| 379 | Site Reference ID/Investigator# 30889 | Toronto | Ontario | Canada | M6G 1C9 |
| 380 | Site Reference ID/Investigator# 30934 | Toronto | Ontario | Canada | M6G 1C9 |
| 381 | Site Reference ID/Investigator# 30869 | Toronto | Ontario | Canada | M6G 1L4 |
| 382 | Site Reference ID/Investigator# 42405 | Toronto | Ontario | Canada | M6G 4A1 |
| 383 | Site Reference ID/Investigator# 42430 | Toronto | Ontario | Canada | M6H 4H4 |
| 384 | Site Reference ID/Investigator# 31377 | Toronto | Ontario | Canada | M6J 1J6 |
| 385 | Site Reference ID/Investigator# 42432 | Toronto | Ontario | Canada | M6N 4B3 |
| 386 | Site Reference ID/Investigator# 32550 | Toronto | Ontario | Canada | M6R 1V7 |
| 387 | Site Reference ID/Investigator# 32547 | Toronto | Ontario | Canada | M6R 1X7 |
| 388 | Site Reference ID/Investigator# 37917 | Toronto | Ontario | Canada | M6R 2L3 |
| 389 | Site Reference ID/Investigator# 42366 | Toronto | Ontario | Canada | M6R 3A9 |
| 390 | Site Reference ID/Investigator# 31378 | Toronto | Ontario | Canada | M8X 2W2 |
| 391 | Site Reference ID/Investigator# 32161 | Toronto | Ontario | Canada | M9R 4E1 |
| 392 | Site Reference ID/Investigator# 47564 | Totonto | Ontario | Canada | M4X 1G8 |
| 393 | Site Reference ID/Investigator# 42372 | Waterdown | Ontario | Canada | L0R 2H4 |
| 394 | Site Reference ID/Investigator# 30902 | Welland | Ontario | Canada | L3B 3C4 |
| 395 | Site Reference ID/Investigator# 32142 | Welland | Ontario | Canada | L3B 3E1 |
| 396 | Site Reference ID/Investigator# 31337 | Welland | Ontario | Canada | L3C 5E6 |
| 397 | Site Reference ID/Investigator# 37883 | Whitby | Ontario | Canada | L1N 3V6 |
| 398 | Site Reference ID/Investigator# 37927 | Whitby | Ontario | Canada | L1N 3V6 |
| 399 | Site Reference ID/Investigator# 37928 | Whitby | Ontario | Canada | L1N 4P8 |
| 400 | Site Reference ID/Investigator# 30931 | Whitby | Ontario | Canada | L1N 8M7 |
| 401 | Site Reference ID/Investigator# 37905 | Whitby | Ontario | Canada | L1N 8M7 |
| 402 | Site Reference ID/Investigator# 37926 | Whitby | Ontario | Canada | L1R 3E1 |
| 403 | Site Reference ID/Investigator# 47577 | Whitby | Ontario | Canada | L1R 3E1 |
| 404 | Site Reference ID/Investigator# 30944 | Willowdale | Ontario | Canada | M2K 1B7 |
| 405 | Site Reference ID/Investigator# 33163 | Windsor | Ontario | Canada | B0N 2T0 |
| 406 | Site Reference ID/Investigator# 37841 | Windsor | Ontario | Canada | N8R 1W6 |
| 407 | Site Reference ID/Investigator# 37776 | Windsor | Ontario | Canada | N8S 1S6 |
| 408 | Site Reference ID/Investigator# 42364 | Windsor | Ontario | Canada | N8S 1S8 |
| 409 | Site Reference ID/Investigator# 30941 | Windsor | Ontario | Canada | N8W 1C9 |
| 410 | Site Reference ID/Investigator# 37738 | Windsor | Ontario | Canada | N8W 1E6 |
| 411 | Site Reference ID/Investigator# 37912 | Windsor | Ontario | Canada | N8W 1E7 |
| 412 | Site Reference ID/Investigator# 30972 | Windsor | Ontario | Canada | N8W 5L7 |
| 413 | Site Reference ID/Investigator# 42346 | Windsor | Ontario | Canada | N8W 5X8 |
| 414 | Site Reference ID/Investigator# 31272 | Windsor | Ontario | Canada | N8X 1K3 |
| 415 | Site Reference ID/Investigator# 42339 | Windsor | Ontario | Canada | N8X 3N9 |
| 416 | Site Reference ID/Investigator# 42456 | Windsor | Ontario | Canada | N8X 3N9 |
| 417 | Site Reference ID/Investigator# 33164 | Windsor | Ontario | Canada | N8X 3V6 |
| 418 | Site Reference ID/Investigator# 31330 | Windsor | Ontario | Canada | N8X 4T2 |
| 419 | Site Reference ID/Investigator# 30875 | Windsor | Ontario | Canada | N9A 4B9 |
| 420 | Site Reference ID/Investigator# 42428 | Windsor | Ontario | Canada | N9A 6W8 |
| 421 | Site Reference ID/Investigator# 42453 | Windsor | Ontario | Canada | N9E 1H1 |
| 422 | Site Reference ID/Investigator# 32150 | Windsor | Ontario | Canada | N9E 1S4 |
| 423 | Site Reference ID/Investigator# 47574 | Windsor | Ontario | Canada | N9E 1S4 |
| 424 | Site Reference ID/Investigator# 42465 | Windsor | Ontario | Canada | N9G 3N9 |
| 425 | Site Reference ID/Investigator# 42371 | Woodbridge | Ontario | Canada | L4H 2Z7 |
| 426 | Site Reference ID/Investigator# 31309 | Woodbridge | Ontario | Canada | L4L 3R1 |
| 427 | Site Reference ID/Investigator# 32153 | Woodstock | Ontario | Canada | N4S 5B2 |
| 428 | Site Reference ID/Investigator# 42450 | York | Ontario | Canada | M6B 4J3 |
| 429 | Site Reference ID/Investigator# 33186 | York | Ontario | Canada | M6N 4N6 |
| 430 | Site Reference ID/Investigator# 31273 | York | Ontario | Canada | M9N 1J4 |
| 431 | Site Reference ID/Investigator# 32145 | Charlottetown | Prince Edward Island | Canada | C1A 1L2 |
| 432 | Site Reference ID/Investigator# 32195 | Charlottetown | Prince Edward Island | Canada | C1A 2M5 |
| 433 | Site Reference ID/Investigator# 32221 | Charlottetown | Prince Edward Island | Canada | C1A 6Y1 |
| 434 | Site Reference ID/Investigator# 37897 | Cornwall | Prince Edward Island | Canada | C0A 1H0 |
| 435 | Site Reference ID/Investigator# 33019 | Kensington | Prince Edward Island | Canada | C0B 1M0 |
| 436 | Site Reference ID/Investigator# 42470 | Summerside | Prince Edward Island | Canada | C1N 4N6 |
| 437 | Site Reference ID/Investigator# 31267 | Alma | Quebec | Canada | G8E 2K2 |
| 438 | Site Reference ID/Investigator# 37942 | Alma | Quebec | Canada | G8E 2K2 |
| 439 | Site Reference ID/Investigator# 30885 | Anjou | Quebec | Canada | H1M 3M4 |
| 440 | Site Reference ID/Investigator# 31331 | Aylmer | Quebec | Canada | N5H 1K9 |
| 441 | Site Reference ID/Investigator# 31304 | Beauceville | Quebec | Canada | G5X 1J9 |
| 442 | Site Reference ID/Investigator# 31369 | Bromont | Quebec | Canada | J2L 2C3 |
| 443 | Site Reference ID/Investigator# 30903 | Brossard | Quebec | Canada | J4Z 3G9 |
| 444 | Site Reference ID/Investigator# 42335 | Chicoutimi | Quebec | Canada | G7H 1G8 |
| 445 | Site Reference ID/Investigator# 31260 | Chicoutimi | Quebec | Canada | G7J 2V1 |
| 446 | Site Reference ID/Investigator# 31398 | Clemont | Quebec | Canada | G4A 1G3 |
| 447 | Site Reference ID/Investigator# 30911 | Clermont | Quebec | Canada | G4A 1G3 |
| 448 | Site Reference ID/Investigator# 31323 | Clermont | Quebec | Canada | G4A 1G3 |
| 449 | Site Reference ID/Investigator# 30928 | Cote-St-Luc | Quebec | Canada | H3W 1Z7 |
| 450 | Site Reference ID/Investigator# 42386 | Dolbeau-Mistassini | Quebec | Canada | G8L 1H1 |
| 451 | Site Reference ID/Investigator# 31281 | Dolbeau-Mistassini | Quebec | Canada | G8L 5J8 |
| 452 | Site Reference ID/Investigator# 32182 | Gatineau | Quebec | Canada | J8X 4B6 |
| 453 | Site Reference ID/Investigator# 37937 | Gatineau | Quebec | Canada | J8X 4B7 |
| 454 | Site Reference ID/Investigator# 37843 | Gatineau | Quebec | Canada | J8Y 1W7 |
| 455 | Site Reference ID/Investigator# 32910 | Gatineau | Quebec | Canada | J8Y 3B5 |
| 456 | Site Reference ID/Investigator# 32911 | Gatineau | Quebec | Canada | J8Y 6S9 |
| 457 | Site Reference ID/Investigator# 37941 | Gatineau | Quebec | Canada | J9J 2M9 |
| 458 | Site Reference ID/Investigator# 31393 | Grand-Mere | Quebec | Canada | G9T 2J1 |
| 459 | Site Reference ID/Investigator# 31379 | Grand-Mere | Quebec | Canada | G9T 3S7 |
| 460 | Site Reference ID/Investigator# 37852 | Grand-Mere | Quebec | Canada | G9T 3S7 |
| 461 | Site Reference ID/Investigator# 32141 | Grand-Mere | Quebec | Canada | G9T 4T8 |
| 462 | Site Reference ID/Investigator# 47572 | Grande-Allee | Quebec | Canada | J7G 1W6 |
| 463 | Site Reference ID/Investigator# 30904 | Greenfield Park | Quebec | Canada | J4V 2G8 |
| 464 | Site Reference ID/Investigator# 32966 | Hebertville | Quebec | Canada | G8B 1N3 |
| 465 | Site Reference ID/Investigator# 32167 | Hull | Quebec | Canada | J8Y 6S9 |
| 466 | Site Reference ID/Investigator# 31298 | Kirkland | Quebec | Canada | H9J 2W2 |
| 467 | Site Reference ID/Investigator# 32189 | L'anse-saint-jean | Quebec | Canada | G0V 1J0 |
| 468 | Site Reference ID/Investigator# 42344 | La Baie | Quebec | Canada | G7B 0A3 |
| 469 | Site Reference ID/Investigator# 42343 | La Malbaie | Quebec | Canada | G5A 1W7 |
| 470 | Site Reference ID/Investigator# 33042 | La Salle | Quebec | Canada | N9J 2C1 |
| 471 | Site Reference ID/Investigator# 42377 | Lachenaie | Quebec | Canada | J6V 1S8 |
| 472 | Site Reference ID/Investigator# 30877 | Lachute | Quebec | Canada | J8H 1S4 |
| 473 | Site Reference ID/Investigator# 30968 | Lasalle | Quebec | Canada | H8N 1T5 |
| 474 | Site Reference ID/Investigator# 30918 | Lasalle | Quebec | Canada | H8N 1X9 |
| 475 | Site Reference ID/Investigator# 33046 | Laval | Quebec | Canada | H7K 2J4 |
| 476 | Site Reference ID/Investigator# 31397 | Laval | Quebec | Canada | H7L 3A2 |
| 477 | Site Reference ID/Investigator# 37855 | Laval | Quebec | Canada | H7P 5L3 |
| 478 | Site Reference ID/Investigator# 37856 | Laval | Quebec | Canada | H7P 5L3 |
| 479 | Site Reference ID/Investigator# 42437 | Laval | Quebec | Canada | H7P 5L3 |
| 480 | Site Reference ID/Investigator# 30871 | Laval | Quebec | Canada | H7V 2W2 |
| 481 | Site Reference ID/Investigator# 42402 | Laval | Quebec | Canada | H7X 3S5 |
| 482 | Site Reference ID/Investigator# 31362 | Levis | Quebec | Canada | G0R 3E0 |
| 483 | Site Reference ID/Investigator# 33062 | Levis | Quebec | Canada | G6V 8V3 |
| 484 | Site Reference ID/Investigator# 31371 | Longueuil | Quebec | Canada | J4J 3X5 |
| 485 | Site Reference ID/Investigator# 30909 | Mistassini | Quebec | Canada | G8L 5J8 |
| 486 | Site Reference ID/Investigator# 37851 | Montreal | Quebec | Canada | H1L 2N9 |
| 487 | Site Reference ID/Investigator# 31324 | Montreal | Quebec | Canada | H1T 1S6 |
| 488 | Site Reference ID/Investigator# 31308 | Montreal | Quebec | Canada | H1T 2M4 |
| 489 | Site Reference ID/Investigator# 33115 | Montreal | Quebec | Canada | H1V 1X4 |
| 490 | Site Reference ID/Investigator# 42394 | Montreal | Quebec | Canada | H1W 1S5 |
| 491 | Site Reference ID/Investigator# 30921 | Montreal | Quebec | Canada | H1X 1R6 |
| 492 | Site Reference ID/Investigator# 31390 | Montreal | Quebec | Canada | H1X 1R6 |
| 493 | Site Reference ID/Investigator# 33111 | Montreal | Quebec | Canada | H1X 1R6 |
| 494 | Site Reference ID/Investigator# 33110 | Montreal | Quebec | Canada | H2N 2H7 |
| 495 | Site Reference ID/Investigator# 42395 | Montreal | Quebec | Canada | H2S 2W1 |
| 496 | Site Reference ID/Investigator# 30905 | Montreal | Quebec | Canada | H3K 1W7 |
| 497 | Site Reference ID/Investigator# 33112 | Montreal | Quebec | Canada | H3L 2E8 |
| 498 | Site Reference ID/Investigator# 30950 | Montreal | Quebec | Canada | H3M 3A9 |
| 499 | Site Reference ID/Investigator# 31279 | Montreal | Quebec | Canada | H3M 3E2 |
| 500 | Site Reference ID/Investigator# 31293 | Montreal | Quebec | Canada | H3M 3E2 |
| 501 | Site Reference ID/Investigator# 31294 | Montreal | Quebec | Canada | H3S 1Z4 |
| 502 | Site Reference ID/Investigator# 33114 | Montreal | Quebec | Canada | H3S 1Z6 |
| 503 | Site Reference ID/Investigator# 33116 | Montreal | Quebec | Canada | H3S 2B2 |
| 504 | Site Reference ID/Investigator# 31311 | Montreal | Quebec | Canada | H3Z 1X5 |
| 505 | Site Reference ID/Investigator# 32158 | Montreal | Quebec | Canada | H4E 2K9 |
| 506 | Site Reference ID/Investigator#42324 | Paspebiac | Quebec | Canada | G0C 2K0 |
| 507 | Site Reference ID/Investigator# 31372 | Plessisville | Quebec | Canada | G6L 3J1 |
| 508 | Site Reference ID/Investigator# 32133 | Plessisville | Quebec | Canada | G6L 3J1 |
| 509 | Site Reference ID/Investigator# 32437 | Plessisville | Quebec | Canada | G6L 3J1 |
| 510 | Site Reference ID/Investigator# 31370 | Pohenegamook | Quebec | Canada | G0L 1J0 |
| 511 | Site Reference ID/Investigator# 31358 | Pointe Claire | Quebec | Canada | H9R 2Y2 |
| 512 | Site Reference ID/Investigator# 37854 | Pointe-Aux-Trembles | Quebec | Canada | H1B 2Z1 |
| 513 | Site Reference ID/Investigator# 31332 | Pointe-Claire | Quebec | Canada | H9R 2V7 |
| 514 | Site Reference ID/Investigator# 31392 | Princeville | Quebec | Canada | G6L 4E8 |
| 515 | Site Reference ID/Investigator# 32228 | Quebec City | Quebec | Canada | G1J 1Z6 |
| 516 | Site Reference ID/Investigator# 32482 | Roxton Pond | Quebec | Canada | J0E 1Z0 |
| 517 | Site Reference ID/Investigator# 37894 | Saint Pascal | Quebec | Canada | G0L 3Y0 |
| 518 | Site Reference ID/Investigator# 31351 | Saint-Charles-Borromee | Quebec | Canada | J6E 2C5 |
| 519 | Site Reference ID/Investigator# 32488 | Saint-Lambert-de-Lauzon | Quebec | Canada | G0S 2W0 |
| 520 | Site Reference ID/Investigator# 32490 | Saint-Laurent | Quebec | Canada | H4R 1J9 |
| 521 | Site Reference ID/Investigator# 32605 | Saint-Leonard | Quebec | Canada | H1S 3A9 |
| 522 | Site Reference ID/Investigator# 32134 | Saint-Nicolas | Quebec | Canada | G7A 3S8 |
| 523 | Site Reference ID/Investigator# 31361 | Saint-Pie | Quebec | Canada | J0H 1W0 |
| 524 | Site Reference ID/Investigator# 37857 | Saint-Raymond | Quebec | Canada | G3L 1K7 |
| 525 | Site Reference ID/Investigator# 32135 | Sainte Catherine | Quebec | Canada | G3N 2T6 |
| 526 | Site Reference ID/Investigator# 32188 | Sainte-Claire | Quebec | Canada | G0R 2V0 |
| 527 | Site Reference ID/Investigator# 31266 | Sainte-Julienne | Quebec | Canada | J0K 2T0 |
| 528 | Site Reference ID/Investigator# 32202 | Shefford | Quebec | Canada | J2M 1X4 |
| 529 | Site Reference ID/Investigator# 31344 | Sherbrooke | Quebec | Canada | J1H 1Z1 |
| 530 | Site Reference ID/Investigator# 32509 | Sherbrooke | Quebec | Canada | J1H 1Z1 |
| 531 | Site Reference ID/Investigator# 31343 | St Catherine | Quebec | Canada | J5C 1A2 |
| 532 | Site Reference ID/Investigator# 31289 | St-Anselme | Quebec | Canada | G0R 2N0 |
| 533 | Site Reference ID/Investigator# 42454 | St-Bruno | Quebec | Canada | G0W 2L0 |
| 534 | Site Reference ID/Investigator# 30883 | St-Henri | Quebec | Canada | G0R 3E0 |
| 535 | Site Reference ID/Investigator# 31297 | St-Jerome | Quebec | Canada | J7Z 1Y5 |
| 536 | Site Reference ID/Investigator# 32526 | St-Stanislas-De-Champlain | Quebec | Canada | G0X 3E0 |
| 537 | Site Reference ID/Investigator# 32528 | St-Zacharie | Quebec | Canada | G0M 2C0 |
| 538 | Site Reference ID/Investigator# 31283 | St. Ambroise | Quebec | Canada | G7P 2K6 |
| 539 | Site Reference ID/Investigator# 31341 | Ste Felicite | Quebec | Canada | G0J 2K0 |
| 540 | Site Reference ID/Investigator# 32222 | Ste Marie de Beauce | Quebec | Canada | G6E 1N7 |
| 541 | Site Reference ID/Investigator# 37844 | Ste-Adele | Quebec | Canada | J8B 1W8 |
| 542 | Site Reference ID/Investigator# 42380 | Ste-Marthe-sur-le-Lac | Quebec | Canada | J0N 1P0 |
| 543 | Site Reference ID/Investigator# 31262 | Verdun | Quebec | Canada | H4H 1R3 |
| 544 | Site Reference ID/Investigator# 30897 | Waterville | Quebec | Canada | J0B 3H0 |
| 545 | Site Reference ID/Investigator# 33157 | Westmount | Quebec | Canada | H3Z 1X5 |
| 546 | Site Reference ID/Investigator# 32183 | Westmount | Quebec | Canada | H3Z 2A4 |
| 547 | Site Reference ID/Investigator# 37782 | Craik | Saskatchewan | Canada | S0G 0V0 |
| 548 | Site Reference ID/Investigator# 33232 | North Battleford | Saskatchewan | Canada | S9A 0V6 |
| 549 | Site Reference ID/Investigator# 33233 | North Battleford | Saskatchewan | Canada | S9A 0V6 |
| 550 | Site Reference ID/Investigator# 31366 | North Battleford | Saskatchewan | Canada | S9A 3G8 |
| 551 | Site Reference ID/Investigator# 30881 | Regina | Saskatchewan | Canada | S4P 1E5 |
| 552 | Site Reference ID/Investigator# 37726 | Regina | Saskatchewan | Canada | S4P 3X3 |
| 553 | Site Reference ID/Investigator# 32176 | Regina | Saskatchewan | Canada | S4T 0X4 |
| 554 | Site Reference ID/Investigator# 32123 | Rosetown | Saskatchewan | Canada | S0L 2V0 |
| 555 | Site Reference ID/Investigator# 31317 | Saskatoon | Saskatchewan | Canada | S7H 5M3 |
| 556 | Site Reference ID/Investigator# 32179 | Saskatoon | Saskatchewan | Canada | S7H 5M3 |
| 557 | Site Reference ID/Investigator# 32208 | Saskatoon | Saskatchewan | Canada | S7H 5M3 |
| 558 | Site Reference ID/Investigator# 37887 | Saskatoon | Saskatchewan | Canada | S7K 0H6 |
| 559 | Site Reference ID/Investigator# 31292 | Saskatoon | Saskatchewan | Canada | S7K 3H3 |
| 560 | Site Reference ID/Investigator# 32225 | Saskatoon | Saskatchewan | Canada | S7K 6N9 |
| 561 | Site Reference ID/Investigator# 32493 | Saskatoon | Saskatchewan | Canada | S7L 5L3 |
| 562 | Site Reference ID/Investigator# 31387 | Saskatoon | Saskatchewan | Canada | S7M 0V7 |
| 563 | Site Reference ID/Investigator# 30917 | Saskatoon | Saskatchewan | Canada | S7N 4S1 |
| 564 | Site Reference ID/Investigator# 32449 | Quebec | Canada | G1C 5R9 | |
| 565 | Site Reference ID/Investigator# 32159 | Quebec | Canada | G1G 3Z4 | |
| 566 | Site Reference ID/Investigator# 31325 | Quebec | Canada | G1K 1K1 | |
| 567 | Site Reference ID/Investigator# 32603 | Quebec | Canada | G1V 4T3 | |
| 568 | Site Reference ID/Investigator# 32186 | Quebec | Canada | G1X 4S9 |
Sponsors and Collaborators
- Abbott
- McKesson Canada
Investigators
- Study Director: Linda Assouline, PhD, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Abbott
ClinicalTrials.gov Identifier:
NCT01078584
Other Study ID Numbers:
- P10-665
First Posted:
Mar 2, 2010
Last Update Posted:
Oct 25, 2012
Last Verified:
Oct 1, 2012
Keywords provided by Abbott
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 7993 participants were enrolled at 568 study sites in Canada over a period of 24 months. |
|---|---|
| Pre-assignment Detail | Although 3 participants were considered to have violated the protocol because they were not adults (ie, </= 18 years old), they were included in the Intention-to-Treat (ITT) cohort. |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Period Title: Overall Study | |
| STARTED | 7993 |
| Participants Conducted Visit 2 (3-month) | 7125 |
| Participants Conducted Visit 3 (6-month) | 5833 |
| Participants Conducted Visit 4(12-month) | 4983 |
| COMPLETED | 4983 |
| NOT COMPLETED | 3010 |
Baseline Characteristics
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Overall Participants | 7993 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
58.3
(13.1)
|
| Sex/Gender, Customized (participants) [Number] | |
| Female |
3677
46%
|
| Male |
4283
53.6%
|
| Unknown |
33
0.4%
|
| Region of Enrollment (participants) [Number] | |
| Canada |
7993
100%
|
| Baseline Estimated Glomerular Filtration Rate (eGFR) (mL/min) [Mean (Standard Deviation) ] | |
| All Participants (n=3965) |
76.9
(20.3)
|
| Diabetic Participants (n=1178) |
77.7
(24.2)
|
| Baseline Microalbuminuria (MAU) (mg/L) [Mean (Standard Deviation) ] | |
| All Participants (n=2476) |
36.5
(142.2)
|
| Diabetic Participants (n=1009) |
55.1
(191.5)
|
| Baseline Systolic Blood Pressure (SBP) (mm Hg) [Mean (Standard Deviation) ] | |
| All Participants (n=7992) |
150.8
(15.6)
|
| Diabetic Participants (n=1883) |
145.8
(15.7)
|
| Renal Dysfunction Participants (n=196) |
147.6
(17.1)
|
| ISH Participants (n=2207) |
153.0
(10.9)
|
| Baseline Diastolic Blood Pressure (DBP) (mm Hg) [Mean (Standard Deviation) ] | |
| All Participants (n=7991) |
89.7
(10.7)
|
| Diabetic Participants (n=1883) |
85.7
(10.5)
|
| Renal Dysfunction Participants (n=196) |
83.0
(12.0)
|
Outcome Measures
| Title | Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months |
|---|---|
| Description | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants. |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point). |
| Arm/Group Title | Non-Diabetic Cohort | Diabetic Cohort |
|---|---|---|
| Arm/Group Description | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 5275 | 1605 |
| Number [percentage of participants] |
56.0
0.7%
|
28.2
NaN
|
| Title | Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months |
|---|---|
| Description | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point). |
| Arm/Group Title | Non-Diabetic Cohort | Diabetic Cohort |
|---|---|---|
| Arm/Group Description | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 4374 | 1347 |
| Number [percentage of participants] |
66.2
0.8%
|
31.1
NaN
|
| Title | Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months |
|---|---|
| Description | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point). |
| Arm/Group Title | Non-Diabetic Cohort | Diabetic Cohort |
|---|---|---|
| Arm/Group Description | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 3751 | 1174 |
| Number [percentage of participants] |
72.9
0.9%
|
34.4
NaN
|
| Title | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months |
|---|---|
| Description | Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg. |
| Time Frame | Baseline, 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (diabetic ITT participants with eGFR measurement at given time point). |
| Arm/Group Title | Diabetic Cohort | Diabetic Cohort: BP-Controlled | Diabetic Cohort: BP-Uncontrolled |
|---|---|---|---|
| Arm/Group Description | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg. |
| Measure Participants | 472 | 153 | 319 |
| Mean (95% Confidence Interval) [mL/min] |
0.7
|
-1.5
|
1.7
|
| Title | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months |
|---|---|
| Description | Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg. |
| Time Frame | Baseline, 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (diabetic ITT participants with eGFR measurement at given time point). |
| Arm/Group Title | Diabetic Cohort | Diabetic Cohort: BP-Controlled | Diabetic Cohort: BP-Uncontrolled |
|---|---|---|---|
| Arm/Group Description | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg. |
| Measure Participants | 399 | 133 | 266 |
| Mean (95% Confidence Interval) [mL/min] |
0.0
|
0.7
|
-0.4
|
| Title | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months |
|---|---|
| Description | Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg. |
| Time Frame | Baseline,12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (diabetic ITT participants with eGFR measurement at given time point). |
| Arm/Group Title | Diabetic Cohort | Diabetic Cohort: BP-Controlled | Diabetic Cohort: BP-Uncontrolled |
|---|---|---|---|
| Arm/Group Description | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg. |
| Measure Participants | 409 | 148 | 261 |
| Mean (95% Confidence Interval) [mL/min] |
0.8
|
1.5
|
0.4
|
| Title | Change From Baseline in Microalbuminuria (MAU) at 3 Months |
|---|---|
| Description | |
| Time Frame | Baseline, 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (all participants in the ITT cohort with MAU measurement at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 764 |
| Mean (95% Confidence Interval) [mg/L] |
-6.8
|
| Title | Change From Baseline in Microalbuminuria (MAU) at 6 Months |
|---|---|
| Description | |
| Time Frame | Baseline, 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 652 |
| Mean (95% Confidence Interval) [mg/L] |
-5.3
|
| Title | Change From Baseline in Microalbuminuria (MAU) at 12 Months |
|---|---|
| Description | |
| Time Frame | Baseline, 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 717 |
| Mean (95% Confidence Interval) [mg/L] |
-6.9
|
| Title | Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy |
|---|---|
| Description | The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled." |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint). |
| Arm/Group Title | Isolated Systolic Hypertension Cohort |
|---|---|
| Arm/Group Description | The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 1953 |
| Number [percentage of participants] |
58.4
0.7%
|
| Title | Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy |
|---|---|
| Description | The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled." |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint). |
| Arm/Group Title | Isolated Systolic Hypertension Cohort |
|---|---|
| Arm/Group Description | The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 1617 |
| Number [percentage of participants] |
67.6
0.8%
|
| Title | Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy |
|---|---|
| Description | The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled." |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint). |
| Arm/Group Title | Isolated Systolic Hypertension Cohort |
|---|---|
| Arm/Group Description | The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 1420 |
| Number [percentage of participants] |
74.2
0.9%
|
| Title | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy |
|---|---|
| Description | Satisfaction with therapy at baseline (BL) and 12 months, using a 5-point Likert scale where participants responded to the question "Are you satisfied with your current hypertension therapy?". The range of responses varied from "1 = not at all satisfied" to "5 = extremely satisfied." Responses "2" through "4" were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively. |
| Time Frame | Day 0 (Baseline), 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT cohort. n=evaluable participants from the ITT cohort who answered the satisfaction questions at Baseline and 12-Month visits. |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 7993 |
| Score=1 at BL (n=7212) |
28.4
0.4%
|
| Score=2 at BL (n=7212) |
26.8
0.3%
|
| Score=3 at BL (n=7212) |
30.7
0.4%
|
| Score=4 at BL (n=7212) |
10.3
0.1%
|
| Score=5 at BL (n=7212) |
3.8
0%
|
| Score=1 at 12 Months (n=4928) |
1.8
0%
|
| Score=2 at 12 Months (n=4928) |
3.5
0%
|
| Score=3 at 12 Months (n=4928) |
9.4
0.1%
|
| Score=4 at 12 Months (n=4928) |
33.6
0.4%
|
| Score=5 at 12 Months (n=4928) |
51.7
0.6%
|
| Title | Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy |
|---|---|
| Description | Blood Pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled." |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 6880 |
| Number [percentage of participants] |
58.3
0.7%
|
| Title | Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy |
|---|---|
| Description | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled." |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 5721 |
| Number [percentage of participants] |
68.1
0.9%
|
| Title | Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy |
|---|---|
| Description | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled." |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 4925 |
| Number [percentage of participants] |
74.4
0.9%
|
| Title | Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy |
|---|---|
| Description | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled." |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint). |
| Arm/Group Title | Renal Dysfunction Cohort |
|---|---|
| Arm/Group Description | The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 172 |
| Number [percentage of participants] |
29.1
0.4%
|
| Title | Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy |
|---|---|
| Description | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled." |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint). |
| Arm/Group Title | Renal Dysfunction Cohort |
|---|---|
| Arm/Group Description | The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 131 |
| Number [percentage of participants] |
31.3
0.4%
|
| Title | Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy |
|---|---|
| Description | Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled." |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint). |
| Arm/Group Title | Renal Dysfunction Cohort |
|---|---|
| Arm/Group Description | The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 112 |
| Number [percentage of participants] |
36.6
0.5%
|
| Title | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months |
|---|---|
| Description | |
| Time Frame | Day 0 (Baseline), 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT cohort. n = all evaluable participants in the ITT cohort with blood pressure measurement at given timepoint. |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 7993 |
| SBP (n=6881) |
-16.5
|
| DBP (n=6880) |
-8.4
|
| Title | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months |
|---|---|
| Description | |
| Time Frame | Day 0 (Baseline), 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 5721 |
| SBP |
-18.7
|
| DBP |
-9.7
|
| Title | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months |
|---|---|
| Description | |
| Time Frame | Day 0 (Baseline), 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (participants in the ITT cohort with blood pressure measurements at given timepoint). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 4925 |
| SBP |
-20.1
|
| DBP |
-10.5
|
| Title | Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts |
|---|---|
| Description | |
| Time Frame | Day 0 (Baseline) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint). |
| Arm/Group Title | Non-Diabetic Cohort | Diabetic Cohort | Isolated Systolic Hypertension Cohort | Renal Dysfunction Cohort |
|---|---|---|---|---|
| Arm/Group Description | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 6108 | 1883 | 2207 | 196 |
| SBP |
152.4
|
145.8
|
153.3
|
147.6
|
| DBP |
90.9
|
85.7
|
80.2
|
83.0
|
| Title | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 |
|---|---|
| Description | |
| Time Frame | Day 0 (Baseline), Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint). |
| Arm/Group Title | Non-Diabetic Cohort | Diabetic Cohort | Isolated Systolic Hypertension Cohort | Renal Dysfunction Cohort |
|---|---|---|---|---|
| Arm/Group Description | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 5275 | 1605 | 1953 | 172 |
| SBP |
-17.4
|
-13.6
|
-17.2
|
-14.8
|
| DBP |
-8.8
|
-7.0
|
-2.5
|
-6.9
|
| Title | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 |
|---|---|
| Description | |
| Time Frame | Day 0 (Baseline), Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint). |
| Arm/Group Title | Non-Diabetic Cohort | Diabetic Cohort | Isolated Systolic Hypertension Cohort | Renal Dysfunction Cohort |
|---|---|---|---|---|
| Arm/Group Description | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 4374 | 1347 | 1617 | 131 |
| SBP |
-19.8
|
-15.3
|
-19.2
|
-17.5
|
| DBP |
-10.3
|
-7.9
|
-2.9
|
-8.2
|
| Title | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 |
|---|---|
| Description | |
| Time Frame | Day 0 (Baseline), Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint). |
| Arm/Group Title | Non-Diabetic Cohort | Diabetic Cohort | Isolated Systolic Hypertension Cohort | Renal Dysfunction Cohort |
|---|---|---|---|---|
| Arm/Group Description | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 3751 | 1174 | 1420 | 112 |
| SBP |
-21.2
|
-16.7
|
-20.5
|
-18.3
|
| DBP |
-11.0
|
-8.8
|
-3.6
|
-9.7
|
| Title | Number of Participants Compliant With Therapy After 3 Months |
|---|---|
| Description | Compliance after 3 months of treatment was derived using responses to the Visit 2 question "How many trandolapril (Mavik®) doses have been missed since the subject's last visit?" If the response was "zero", the participant was classified as "compliant." If the response was any value greater than zero, regardless of the number of missed doses, the participant was classified as "non-compliant." |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (participants in the ITT cohort with compliance data available at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 6716 |
| Number [participants] |
5015
62.7%
|
| Title | Number of Participants Compliant With Therapy After 6 Months |
|---|---|
| Description | Compliance after 6 months of treatment was derived using responses to the question "How many trandolapril (Mavik®) doses have been missed since the subject's last visit?" at both Visit 2 and Visit 3, as follows: If the response was "zero" at both the Visit 2 and Visit 3 assessments, participant was classified as "compliant" after 6 months of treatment; If the response was any value greater than zero at either of the Visit 2 or Visit 3 assessments, regardless of the number of missed doses, participant was classified as "non-compliant" after 6 months of treatment |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (participants in the ITT cohort with compliance data available at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 5588 |
| Number [participants] |
3661
45.8%
|
| Title | Number of Participants Compliant With Therapy After 12 Months |
|---|---|
| Description | Compliance after 12 months of treatment was derived using responses to the question "How many trandolapril doses have been missed since the subject's last visit?" at Visit 2, Visit 3 and Visit 4, as follows: if the response was "zero" at all of the Visits 2 through 4 assessments, the participant was classified as "compliant" after 12 months of treatment; if the response was any value greater than zero at any of the Visits 2 through 4 assessments, regardless of the number of missed doses, the participant was classified as "non-compliant" after 12 months of treatment. |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (participants in the ITT cohort with compliance data available at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 4728 |
| Number [participants] |
2793
34.9%
|
| Title | Number of Participants With Dose Changes at 3 Months |
|---|---|
| Description | |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (all participants in the ITT cohort with data available at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 6456 |
| Dose Decreased |
173
2.2%
|
| Dose Increased |
1868
23.4%
|
| No Change in Dose |
4373
54.7%
|
| Unknown |
42
0.5%
|
| Title | Number of Participants With Dose Changes at 6 Months |
|---|---|
| Description | |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (all participants in the ITT cohort with data available at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 5519 |
| Dose Decreased |
125
1.6%
|
| Dose Increased |
578
7.2%
|
| No Change in Dose |
4735
59.2%
|
| Unknown |
81
1%
|
| Title | Number of Participants With Dose Changes at 12 Months |
|---|---|
| Description | |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (all participants in the ITT cohort with data available at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 4770 |
| Dose Decreased |
100
1.3%
|
| Dose Increased |
370
4.6%
|
| No Change in Dose |
4196
52.5%
|
| Unknown |
104
1.3%
|
| Title | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months |
|---|---|
| Description | The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented. |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point). |
| Arm/Group Title | Non-Diabetic Cohort: BP-Uncontrolled | Non-Diabetic Cohort: BP-Controlled | Diabetic Cohort: BP-Uncontrolled | Diabetic Cohort: BP-Controlled |
|---|---|---|---|---|
| Arm/Group Description | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg. | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. |
| Measure Participants | 2115 | 2760 | 1077 | 413 |
| Dose Increase |
46.7
0.6%
|
17.9
NaN
|
31.4
NaN
|
10.4
NaN
|
| No Dose Increase |
53.3
0.7%
|
82.1
NaN
|
68.6
NaN
|
89.6
NaN
|
| Title | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months |
|---|---|
| Description | The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point). |
| Arm/Group Title | Non-Diabetic Cohort: BP-Uncontrolled | Non-Diabetic Cohort: BP-Controlled | Diabetic Cohort: BP-Uncontrolled | Diabetic Cohort: BP-Controlled |
|---|---|---|---|---|
| Arm/Group Description | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg. | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. |
| Measure Participants | 1357 | 2785 | 870 | 406 |
| Dose Increase |
23.1
0.3%
|
4.9
NaN
|
12.1
NaN
|
5.4
NaN
|
| No Dose Increase |
76.9
1%
|
95.1
NaN
|
87.9
NaN
|
94.6
NaN
|
| Title | Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months |
|---|---|
| Description | The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented. |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point). |
| Arm/Group Title | Non-Diabetic Cohort: BP-Uncontrolled | Non-Diabetic Cohort: BP-Controlled | Diabetic Cohort: BP-Uncontrolled | Diabetic Cohort: BP-Controlled |
|---|---|---|---|---|
| Arm/Group Description | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg. | The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg. | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. |
| Measure Participants | 912 | 2630 | 712 | 393 |
| Dose Increase |
15.7
0.2%
|
5.2
NaN
|
9.6
NaN
|
4.8
NaN
|
| No Dose Increase |
84.3
1.1%
|
94.8
NaN
|
90.4
NaN
|
95.2
NaN
|
| Title | Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months |
|---|---|
| Description | Presented by type of medication added. |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (all participants in the ITT cohort with available data at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 7125 |
| None |
6090
76.2%
|
| Diuretic |
284
3.6%
|
| Angiotensin receptor blocker |
133
1.7%
|
| Calcium channel blocker |
186
2.3%
|
| Beta-blocker |
78
1%
|
| Title | Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months |
|---|---|
| Description | Presented by type of medication added. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (all participants in the ITT cohort with available data at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 5833 |
| None |
5193
65%
|
| Diuretic |
222
2.8%
|
| Angiotensin receptor blocker |
82
1%
|
| Calcium channel blocker |
123
1.5%
|
| Beta-blocker |
41
0.5%
|
| Title | Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months |
|---|---|
| Description | Presented by type of medication added. |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (all participants in the ITT cohort with available data at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 4983 |
| None |
4540
56.8%
|
| Diuretic |
144
1.8%
|
| Angiotensin receptor blocker |
61
0.8%
|
| Calcium channel blocker |
86
1.1%
|
| Beta-blocker |
35
0.4%
|
| Title | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months |
|---|---|
| Description | Presented by type of medication discontinued. |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (all participants in the ITT cohort with available data at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 7125 |
| None |
6656
83.3%
|
| Diuretic |
27
0.3%
|
| Angiotensin-converting-enzyme inhibitor |
4
0.1%
|
| Angiotensin receptor blocker |
6
0.1%
|
| Calcium channel blocker |
22
0.3%
|
| Beta-blocker |
20
0.3%
|
| Title | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months |
|---|---|
| Description | Presented by type of medication discontinued. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (all participants in the ITT cohort with available data at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 5833 |
| None |
5607
70.1%
|
| Diuretic |
24
0.3%
|
| Angiotensin-converting-enzyme inhibitor |
4
0.1%
|
| Angiotensin receptor blocker |
4
0.1%
|
| Calcium channel blocker |
17
0.2%
|
| Beta-blocker |
8
0.1%
|
| Title | Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months |
|---|---|
| Description | Presented by type of medication discontinued. |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (all participants in the ITT cohort with available data at given time point). |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 4983 |
| None |
4823
60.3%
|
| Diuretic |
25
0.3%
|
| Angiotensin-converting-enzyme inhibitor |
2
0%
|
| Angiotensin receptor blocker |
3
0%
|
| Calcium channel blocker |
10
0.1%
|
| Beta-blocker |
6
0.1%
|
| Title | Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months |
|---|---|
| Description | Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled." |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point). |
| Arm/Group Title | Diabetic Cohort | Renal Dysfunction Cohort |
|---|---|---|
| Arm/Group Description | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 1605 | 172 |
| Number [percentage of participants] |
65.7
0.8%
|
66.3
NaN
|
| Title | Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months |
|---|---|
| Description | Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled." |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with blood pressure measurement at given time point). |
| Arm/Group Title | Diabetic Cohort | Renal Dysfunction Cohort |
|---|---|---|
| Arm/Group Description | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 1347 | 131 |
| Number [percentage of participants] |
74.1
0.9%
|
70.2
NaN
|
| Title | Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months |
|---|---|
| Description | Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled." |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point). |
| Arm/Group Title | Diabetic Cohort | Renal Dysfunction Cohort |
|---|---|---|
| Arm/Group Description | The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 1174 | 112 |
| Number [percentage of participants] |
79.2
1%
|
75.0
NaN
|
| Title | Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy |
|---|---|
| Description | Satisfaction with therapy at baseline (BL) versus 12 months, using a 5-point Likert scale where participants responded to the question "Are you satisfied with your current hypertension therapy?". The range of responses varied from "1 = not at all satisfied" to "5 = extremely satisfied." Responses "2" through "4" were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively. |
| Time Frame | Day 0 (Baseline), 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subset of participants from the ITT cohort who answered the satisfaction questions at both the Baseline and 12-Month visits. |
| Arm/Group Title | All Enrolled Participants (ITT Cohort) |
|---|---|
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. |
| Measure Participants | 4510 |
| Score=1 (at BL) / Score=1 (at 12 Months) |
0.62
0%
|
| Score=1 (at BL) / Score=2 (at 12 Months) |
0.67
0%
|
| Score=1 (at BL) / Score=3 (at 12 Months) |
2.33
0%
|
| Score=1 (at BL) / Score=4 (at 12 Months) |
8.36
0.1%
|
| Score=1 (at BL) / Score=5 (at 12 Months) |
15.63
0.2%
|
| Score=2 (at BL) / Score=1 (at 12 Months) |
0.42
0%
|
| Score=2 (at BL) / Score=2 (at 12 Months) |
1.82
0%
|
| Score=2 (at BL) / Score=3 (at 12 Months) |
2.71
0%
|
| Score=2 (at BL) / Score=4 (at 12 Months) |
9.84
0.1%
|
| Score=2 (at BL) / Score=5 (at 12 Months) |
11.82
0.1%
|
| Score=3 (at BL) / Score=1 (at 12 Months) |
0.53
0%
|
| Score=3 (at BL) / Score=2 (at 12 Months) |
0.89
0%
|
| Score=3 (at BL) / Score=3 (at 12 Months) |
3.90
0%
|
| Score=3 (at BL) / Score=4 (at 12 Months) |
12.06
0.2%
|
| Score=3 (at BL) / Score=5 (at 12 Months) |
13.86
0.2%
|
| Score=4 (at BL) / Score=1 (at 12 Months) |
0.07
0%
|
| Score=4 (at BL) / Score=2 (at 12 Months) |
0.09
0%
|
| Score=4 (at BL) / Score=3 (at 12 Months) |
0.53
0%
|
| Score=4 (at BL) / Score=4 (at 12 Months) |
4.12
0.1%
|
| Score=4 (at BL) / Score=5 (at 12 Months) |
5.96
0.1%
|
| Score=5 (at BL) / Score=1 (at 12 Months) |
0.07
0%
|
| Score=5 (at BL) / Score=2 (at 12 Months) |
0.07
0%
|
| Score=5 (at BL) / Score=3 (at 12 Months) |
0.29
0%
|
| Score=5 (at BL) / Score=4 (at 12 Months) |
0.67
0%
|
| Score=5 (at BL) / Score=5 (at 12 Months) |
2.68
0%
|
Adverse Events
| Time Frame | Day 0 to Day 360 | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | All Enrolled Participants (ITT Cohort) | |
| Arm/Group Description | Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. | |
All Cause Mortality |
||
| All Enrolled Participants (ITT Cohort) | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| All Enrolled Participants (ITT Cohort) | ||
| Affected / at Risk (%) | # Events | |
| Total | 83/7993 (1%) | |
| Cardiac disorders | ||
| myocardial infarction | 8/7993 (0.1%) | |
| atrial fibrillation | 5/7993 (0.1%) | |
| angina pectoris | 4/7993 (0.1%) | |
| cardiac arrest | 3/7993 (0%) | |
| cardiac failure | 3/7993 (0%) | |
| cardiac failure congestive | 3/7993 (0%) | |
| acute coronary syndrome | 2/7993 (0%) | |
| cardiac disorder | 2/7993 (0%) | |
| coronary artery disease | 2/7993 (0%) | |
| coronary artery stenosis | 2/7993 (0%) | |
| palpitations | 2/7993 (0%) | |
| ventricular hypokinesis | 1/7993 (0%) | |
| arteriosclerosis coronary artery | 1/7993 (0%) | |
| atrioventricular block | 1/7993 (0%) | |
| bradycardia | 1/7993 (0%) | |
| cardiac tamponade | 1/7993 (0%) | |
| cardiogenic shock | 1/7993 (0%) | |
| cardio-respiratory arrest | 1/7993 (0%) | |
| coronary artery occlusion | 1/7993 (0%) | |
| coronary artery thrombosis | 1/7993 (0%) | |
| left ventricular dysfunction | 1/7993 (0%) | |
| left ventricular hypertrophy | 1/7993 (0%) | |
| mitral valve disease | 1/7993 (0%) | |
| mitral valve incompetence | 1/7993 (0%) | |
| myocardial ischemia | 1/7993 (0%) | |
| pericardial haemorrhage | 1/7993 (0%) | |
| right ventricular dysfunction | 1/7993 (0%) | |
| sick sinus syndrome | 1/7993 (0%) | |
| supraventricular tachycardia | 1/7993 (0%) | |
| torsade de pointes | 1/7993 (0%) | |
| ventricular fibrillation | 1/7993 (0%) | |
| Endocrine disorders | ||
| hypothyroidism | 1/7993 (0%) | |
| Eye disorders | ||
| eye haemorrhage | 1/7993 (0%) | |
| ocular vascular disorder | 1/7993 (0%) | |
| visual acuity reduced | 1/7993 (0%) | |
| Gastrointestinal disorders | ||
| abdominal pain | 2/7993 (0%) | |
| pancreatitis acute | 2/7993 (0%) | |
| ascites | 1/7993 (0%) | |
| colitis iscaemic | 1/7993 (0%) | |
| gastric ulcer | 1/7993 (0%) | |
| gastroesophageal reflux disease | 1/7993 (0%) | |
| hiatus hernia | 1/7993 (0%) | |
| lip swelling | 1/7993 (0%) | |
| oedema mouth | 1/7993 (0%) | |
| swollen tongue | 1/7993 (0%) | |
| General disorders | ||
| death | 5/7993 (0.1%) | |
| chest pain | 4/7993 (0.1%) | |
| asthenia | 3/7993 (0%) | |
| fatigue | 2/7993 (0%) | |
| oedema peripheral | 2/7993 (0%) | |
| chest discomfort | 1/7993 (0%) | |
| malaise | 1/7993 (0%) | |
| terminal state | 1/7993 (0%) | |
| Immune system disorders | ||
| amyloidosis | 1/7993 (0%) | |
| Infections and infestations | ||
| pneumonia | 3/7993 (0%) | |
| sepsis | 3/7993 (0%) | |
| gangrene | 1/7993 (0%) | |
| lung infection | 1/7993 (0%) | |
| Injury, poisoning and procedural complications | ||
| fall | 4/7993 (0.1%) | |
| hip fracture | 2/7993 (0%) | |
| post-procedural complication | 2/7993 (0%) | |
| road traffic accident | 2/7993 (0%) | |
| complications of transplanted liver | 1/7993 (0%) | |
| femur fracture | 1/7993 (0%) | |
| foot fracture | 1/7993 (0%) | |
| injury | 1/7993 (0%) | |
| lower limb fracture | 1/7993 (0%) | |
| rib fracture | 1/7993 (0%) | |
| Investigations | ||
| weight decreased | 2/7993 (0%) | |
| blood pressure decreased | 1/7993 (0%) | |
| Metabolism and nutrition disorders | ||
| diabetes mellitus | 2/7993 (0%) | |
| hyponatraemia | 1/7993 (0%) | |
| Musculoskeletal and connective tissue disorders | ||
| pain in extremity | 2/7993 (0%) | |
| lower extremity mass | 1/7993 (0%) | |
| mobility decreased | 1/7993 (0%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| lung neoplasm malignant | 3/7993 (0%) | |
| metastatic neoplasm | 2/7993 (0%) | |
| breast cancer | 2/7993 (0%) | |
| adenocarcinoma | 1/7993 (0%) | |
| colon cancer | 1/7993 (0%) | |
| endometrial cancer | 1/7993 (0%) | |
| hepatic neoplasm | 1/7993 (0%) | |
| lung cancer metastatic | 1/7993 (0%) | |
| lung squamous cell carcinoma stage unspecified | 1/7993 (0%) | |
| metastases to bone | 1/7993 (0%) | |
| multiple myeloma | 1/7993 (0%) | |
| neoplasm malignant | 1/7993 (0%) | |
| pancreatic carcinoma | 1/7993 (0%) | |
| Nervous system disorders | ||
| cerebrovascular accident | 5/7993 (0.1%) | |
| dizziness | 3/7993 (0%) | |
| syncope | 1/7993 (0%) | |
| carotid artery stenosis | 1/7993 (0%) | |
| cerebral hematoma | 1/7993 (0%) | |
| coma | 1/7993 (0%) | |
| dementia | 1/7993 (0%) | |
| loss of consciousness | 1/7993 (0%) | |
| quadriplegia | 1/7993 (0%) | |
| transient ischemic attack | 1/7993 (0%) | |
| VIIth nerve paralysis | 1/7993 (0%) | |
| Psychiatric disorders | ||
| alcoholism | 1/7993 (0%) | |
| completed suicide | 1/7993 (0%) | |
| schizophrenia | 1/7993 (0%) | |
| Renal and urinary disorders | ||
| renal failure | 2/7993 (0%) | |
| glomerulonephritis membranous | 1/7993 (0%) | |
| oliguria | 1/7993 (0%) | |
| proteinuria | 1/7993 (0%) | |
| renal failure acute | 1/7993 (0%) | |
| Reproductive system and breast disorders | ||
| post-menopausal haemorrhage | 1/7993 (0%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| dyspnoea | 5/7993 (0.1%) | |
| cough | 2/7993 (0%) | |
| respiratory failure | 2/7993 (0%) | |
| chronic obstructive pulmonary disease | 1/7993 (0%) | |
| dyspnoea exertional | 1/7993 (0%) | |
| pneumothorax | 1/7993 (0%) | |
| pulmonary embolism | 1/7993 (0%) | |
| respiratory arrest | 1/7993 (0%) | |
| Skin and subcutaneous tissue disorders | ||
| angioedema | 1/7993 (0%) | |
| Social circumstances | ||
| homicide | 1/7993 (0%) | |
| Surgical and medical procedures | ||
| pericardial drainage | 1/7993 (0%) | |
| aortic valve replacement | 1/7993 (0%) | |
| cardiac pacemaker insertion | 1/7993 (0%) | |
| hernia hiatus repair | 1/7993 (0%) | |
| hospitalization | 1/7993 (0%) | |
| knee arthroplasty | 1/7993 (0%) | |
| rotator cuff repair | 1/7993 (0%) | |
| Vascular disorders | ||
| infarction | 2/7993 (0%) | |
| aortic aneurysm | 1/7993 (0%) | |
| arterial occlusive disease | 1/7993 (0%) | |
| arteriosclerosis | 1/7993 (0%) | |
| blood pressure inadequately controlled | 1/7993 (0%) | |
| hypotension | 1/7993 (0%) | |
| peripheral ischaemia | 1/7993 (0%) | |
| peripheral vascular disease | 1/7993 (0%) | |
| shock | 1/7993 (0%) | |
| pulmonary oedema | 3/7993 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| All Enrolled Participants (ITT Cohort) | ||
| Affected / at Risk (%) | # Events | |
| Total | 527/7993 (6.6%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| cough | 527/7993 (6.6%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | Abbott |
| Phone | 800-633-9110 |
Responsible Party:
Abbott
ClinicalTrials.gov Identifier:
NCT01078584
Other Study ID Numbers:
- P10-665
First Posted:
Mar 2, 2010
Last Update Posted:
Oct 25, 2012
Last Verified:
Oct 1, 2012