Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00430508
Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company (Industry)
972
55
4
14.9
17.7
1.2
Study Details
Study Description
Brief Summary
The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
972 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 40 mg Monotherapy
Study Start Date
:
Feb 1, 2007
Actual Primary Completion Date
:
Mar 1, 2008
Actual Study Completion Date
:
May 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 4 olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks |
Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week
|
| Experimental: 1 olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks |
Drug: olmesartan medoxomil/hydrochlorothiazide tablets
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
| Experimental: 3 olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks |
Drug: olmesartan medoxomil/hydrochlorothiazide tablets
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
|
| Experimental: 2 olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks |
Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
|
Outcome Measures
Primary Outcome Measures
- Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16 [8 weeks, change = week 16 - week 8]
Change = Week 16 - Week 8 (baseline).
Secondary Outcome Measures
- Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12. [4 weeks, change = week 12 - week 8]
Change = Week 12 - Week 8 (baseline).
- Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16. [8 weeks, change = week 16 - week 8]
Change = Week 16 - Week 8 (baseline).
- Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12. [4 weeks, change = week 12 - week 8]
Change = Week 12 - Week 8 (baseline).
- Number of Patients Achieving Target Blood Pressure at Week 16 [8 weeks]
Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics
- Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. [8 weeks, change = week 16 - week 8]
Change = Week 16 - Week 8 (baseline).
- Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. [8 weeks, change = week 16 - week 8]
Change = Week 16 - Week 8 (baseline).
- Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. [8 weeks, change = week 16 - week 8]
Change = Week 16 - Week 8 (baseline).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Male or female Europeans aged 18 years or older with moderate to severe hypertension (HTN)
Exclusion Criteria:
-
Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
-
Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
-
Patients having a history of the following within the last six months:
-
myocardial infarction,
-
unstable angina pectoris,
-
percutaneous coronary intervention,
-
severe heart failure,
-
hypertensive encephalopathy,
-
cerebrovascular accident (stroke) or
-
transient ischaemic attack.
-
Patients with clinically significant abnormal laboratory values at screening.
-
Patients with secondary HTN.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pleven | Bulgaria | |||
| 2 | Sofia | Bulgaria | |||
| 3 | Beroun | Czechia | |||
| 4 | Brno | Czechia | |||
| 5 | Chrudim | Czechia | |||
| 6 | Hradec Kralove | Czechia | |||
| 7 | Jindrichuv Hradec | Czechia | |||
| 8 | Kutna Hora | Czechia | |||
| 9 | Ostrava | Czechia | |||
| 10 | Pardubice | Czechia | |||
| 11 | Plzen | Czechia | |||
| 12 | Prague | Czechia | |||
| 13 | Pribram | Czechia | |||
| 14 | Revnice | Czechia | |||
| 15 | Sokolov | Czechia | |||
| 16 | Trutnov | Czechia | |||
| 17 | Langres | France | |||
| 18 | Paris | France | |||
| 19 | Pessac | France | |||
| 20 | Berlin | Germany | |||
| 21 | Bochum | Germany | |||
| 22 | Dietzenbach | Germany | |||
| 23 | Franfurt | Germany | |||
| 24 | Friedberg | Germany | |||
| 25 | Ingelheim | Germany | |||
| 26 | Karlsbad | Germany | |||
| 27 | Leipzig | Germany | |||
| 28 | Offenbach | Germany | |||
| 29 | Siegen | Germany | |||
| 30 | Stuhr-Brinkum | Germany | |||
| 31 | Elblag | Poland | |||
| 32 | Gdansk | Poland | |||
| 33 | Inowroclaw | Poland | |||
| 34 | Katowice | Poland | |||
| 35 | Krakow | Poland | |||
| 36 | Linia | Poland | |||
| 37 | Lodz | Poland | |||
| 38 | Olawa | Poland | |||
| 39 | Poznan | Poland | |||
| 40 | Warszawa | Poland | |||
| 41 | Wroclaw | Poland | |||
| 42 | Zamosc | Poland | |||
| 43 | Girona | Spain | |||
| 44 | Granada | Spain | |||
| 45 | Madrid | Spain | |||
| 46 | Oviedo | Spain | |||
| 47 | Dnepropetrovsk | Ukraine | |||
| 48 | Donetsk | Ukraine | |||
| 49 | Kharkiv | Ukraine | |||
| 50 | Kiev | Ukraine | |||
| 51 | Lviv | Ukraine | |||
| 52 | Odessa | Ukraine | |||
| 53 | Uzhgorod | Ukraine | |||
| 54 | Vinnytsia | Ukraine | |||
| 55 | Zaporizhzhya | Ukraine |
Sponsors and Collaborators
- Daiichi Sankyo, Inc.
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Investigators
- Study Chair: Professor Lars Christian Rump, M.D., University of Ruhr-Bochum
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00430508
Other Study ID Numbers:
- CS866CM-B-E301
First Posted:
Feb 2, 2007
Last Update Posted:
Jan 9, 2019
Last Verified:
Jun 1, 2009
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 78 investigative sites screened patients in Europe (19 in Czech Republic, 11 in Germany, 8 in Bulgaria, 5 in Spain, 20 in Ukraine, 1 in France and 14 in Poland). Sites were either hospitals or general practitioners. First patient in: 17 January 2007 Last patient out: 30 March 2008 |
|---|---|
| Pre-assignment Detail | Trial is 2-week taper-off phase and 2 treatment periods. Period I-8-week open-label, OM 40mg. End of Period I, only non-responders randomised to Period II. Blood Pressure controlled patients discontinued. Period II-8-week double-blind four randomized treatment arms. Participant flow is Period II. 972 completed period I, 971 started period II. |
| Arm/Group Title | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo | OM/HCTZ 20/12.5mg + 40/0 Matching Placebo | OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|---|---|
| Arm/Group Description | olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks | olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks | olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks | olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks |
| Period Title: Overall Study | ||||
| STARTED | 140 | 278 | 279 | 274 |
| COMPLETED | 137 | 272 | 266 | 269 |
| NOT COMPLETED | 3 | 6 | 13 | 5 |
Baseline Characteristics
| Arm/Group Title | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo | OM/HCTZ 20/12.5mg + 40/0 Matching Placebo | OM/HCTZ 40/0mg + 20/12.5 Matching Placebo | Total |
|---|---|---|---|---|---|
| Arm/Group Description | olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks | olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks | olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks | olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks | Total of all reporting groups |
| Overall Participants | 140 | 278 | 279 | 274 | 971 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
122
87.1%
|
240
86.3%
|
233
83.5%
|
238
86.9%
|
833
85.8%
|
| >=65 years |
18
12.9%
|
38
13.7%
|
46
16.5%
|
36
13.1%
|
138
14.2%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
55.2
(8.17)
|
53.7
(9.77)
|
55.2
(9.47)
|
54.1
(8.92)
|
54.5
(9.24)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
52
37.1%
|
105
37.8%
|
100
35.8%
|
115
42%
|
372
38.3%
|
| Male |
88
62.9%
|
173
62.2%
|
179
64.2%
|
159
58%
|
599
61.7%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||
| European |
140
100%
|
278
100%
|
278
99.6%
|
274
100%
|
970.0
99.9%
|
| Other |
0
0%
|
0
0%
|
1
0.4%
|
0
0%
|
1.0
0.1%
|
Outcome Measures
| Title | Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16 |
|---|---|
| Description | Change = Week 16 - Week 8 (baseline). |
| Time Frame | 8 weeks, change = week 16 - week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set-Last Observation Carried Forward. |
| Arm/Group Title | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo | OM/HCTZ 20/12.5mg + 40/0 Matching Placebo | OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|---|---|
| Arm/Group Description | olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks |
| Measure Participants | 140 | 277 | 279 | 274 |
| Mean (Standard Deviation) [mm Hg] |
-11.16
(8.796)
|
-9.13
(8.622)
|
-8.10
(7.968)
|
-5.66
(8.546)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -5.3 | |
| Confidence Interval |
() 95% -6.97 to -3.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -3.4 | |
| Confidence Interval |
() 95% -4.79 to -2.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1788 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.9 | |
| Confidence Interval |
() 95% -2.32 to 0.43 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12. |
|---|---|
| Description | Change = Week 12 - Week 8 (baseline). |
| Time Frame | 4 weeks, change = week 12 - week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set-Last Observation Carried Forward |
| Arm/Group Title | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo | OM/HCTZ 20/12.5mg + 40/0 Matching Placebo | OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|---|---|
| Arm/Group Description | olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks |
| Measure Participants | 140 | 277 | 279 | 274 |
| Mean (Standard Deviation) [mm Hg] |
-8.74
(7.879)
|
-7.72
(7.606)
|
-6.66
(7.090)
|
-4.47
(7.197)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -4.1 | |
| Confidence Interval |
() 95% -5.54 to -2.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -3.2 | |
| Confidence Interval |
() 95% -4.39 to -1.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1081 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -1.0 | |
| Confidence Interval |
() 95% -2.19 to 0.22 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16. |
|---|---|
| Description | Change = Week 16 - Week 8 (baseline). |
| Time Frame | 8 weeks, change = week 16 - week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set-Last Observation Carried Forward. |
| Arm/Group Title | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo | OM/HCTZ 20/12.5mg + 40/0 Matching Placebo | OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|---|---|
| Arm/Group Description | olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks |
| Measure Participants | 140 | 277 | 279 | 274 |
| Mean (Standard Deviation) [mm Hg] |
-16.17
(13.444)
|
-13.52
(14.533)
|
-11.46
(13.673)
|
-8.85
(13.537)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -7.4 | |
| Confidence Interval |
() 95% -10.13 to -4.66 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -5.2 | |
| Confidence Interval |
() 95% -7.4 to -2.91 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0255 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -2.6 | |
| Confidence Interval |
() 95% -4.79 to -0.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12. |
|---|---|
| Description | Change = Week 12 - Week 8 (baseline). |
| Time Frame | 4 weeks, change = week 12 - week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set-Last Observation Carried Forward |
| Arm/Group Title | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo | OM/HCTZ 20/12.5mg + 40/0 Matching Placebo | OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|---|---|
| Arm/Group Description | olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks |
| Measure Participants | 140 | 277 | 279 | 274 |
| Mean (Standard Deviation) [mm Hg] |
-13.16
(13.337)
|
-10.90
(12.297)
|
-9.65
(11.743)
|
-6.60
(10.932)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -6.6 | |
| Confidence Interval |
() 95% -9.00 to -4.26 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -4.8 | |
| Confidence Interval |
() 95% -6.70 to -2.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0812 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -1.7 | |
| Confidence Interval |
() 95% -3.66 to 0.21 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients Achieving Target Blood Pressure at Week 16 |
|---|---|
| Description | Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set-Last Observation Carried Forward |
| Arm/Group Title | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo | OM/HCTZ 20/12.5mg + 40/0 Matching Placebo | OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|---|---|
| Arm/Group Description | olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks |
| Measure Participants | 140 | 277 | 279 | 274 |
| Number [participants] |
59
42.1%
|
110
39.6%
|
88
31.5%
|
68
24.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.67 | |
| Confidence Interval |
() 95% 1.69 to 4.21 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.20 | |
| Confidence Interval |
() 95% 1.50 to 3.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.55 | |
| Confidence Interval |
() 95% 1.07 to 2.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. |
|---|---|
| Description | Change = Week 16 - Week 8 (baseline). |
| Time Frame | 8 weeks, change = week 16 - week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set-Observed Cases |
| Arm/Group Title | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo | OM/HCTZ 20/12.5mg + 40/0 Matching Placebo | OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|---|---|
| Arm/Group Description | olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks |
| Measure Participants | 120 | 250 | 241 | 249 |
| Mean (Standard Deviation) [mm Hg] |
-7.2
(7.62)
|
-5.3
(8.60)
|
-4.1
(9.07)
|
-2.0
(7.64)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -5.1 | |
| Confidence Interval |
() 95% -6.78 to -3.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -3.2 | |
| Confidence Interval |
() 95% -4.54 to -1.78 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1452 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -1.0 | |
| Confidence Interval |
() 95% -2.43 to 0.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. |
|---|---|
| Description | Change = Week 16 - Week 8 (baseline). |
| Time Frame | 8 weeks, change = week 16 - week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set-Observed Cases |
| Arm/Group Title | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo | OM/HCTZ 20/12.5mg + 40/0 Matching Placebo | OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|---|---|
| Arm/Group Description | olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks |
| Measure Participants | 120 | 250 | 241 | 249 |
| Mean (Standard Deviation) [mm Hg] |
-7.0
(8.06)
|
-5.5
(9.10)
|
-4.0
(9.34)
|
-1.8
(8.39)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -5.0 | |
| Confidence Interval |
() 95% -6.79 to -3.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -3.3 | |
| Confidence Interval |
() 95% -4.79 to -1.87 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1629 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -1.0 | |
| Confidence Interval |
() 95% -2.52 to 0.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. |
|---|---|
| Description | Change = Week 16 - Week 8 (baseline). |
| Time Frame | 8 weeks, change = week 16 - week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set-Observed Cases |
| Arm/Group Title | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo | OM/HCTZ 20/12.5mg + 40/0 Matching Placebo | OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|---|---|
| Arm/Group Description | olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks | olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks |
| Measure Participants | 120 | 250 | 241 | 249 |
| Mean (Standard Deviation) [mm Hg] |
-7.9
(9.51)
|
-4.5
(9.90)
|
-4.2
(10.61)
|
-2.3
(8.47)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -5.5 | |
| Confidence Interval |
() 95% -7.40 to -3.62 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0009 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -2.6 | |
| Confidence Interval |
() 95% -4.12 to -1.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1985 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -1.0 | |
| Confidence Interval |
() 95% -2.55 to 0.53 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results of Study shall not be published without prior express written consent and approval of Sponsor. If Contractor wishes to use data generated at Sites by Investigator, such data includes but not limited to data used in collection of metrics, copy of any intended publication, details of use must be sent in writing to Quintiles and Sponsor for review. Sponsor has right to change proposed publication and/or prohibit publication and Contractor must comply with requirements of Sponsor
Results Point of Contact
| Name/Title | James McCarthy / Director Regulatory Operations |
|---|---|
| Organization | Daiichi Sankyo |
| Phone | 732-590-3430 |
| jmccarthy@dsus.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00430508
Other Study ID Numbers:
- CS866CM-B-E301
First Posted:
Feb 2, 2007
Last Update Posted:
Jan 9, 2019
Last Verified:
Jun 1, 2009