FEATHER: Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight With Coronary Artery Disease
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01107925
Collaborator
Daiichi Sankyo Co., Ltd. (Industry)
72
6
3
17
12
0.7
Study Details
Study Description
Brief Summary
The 5-milligram (mg) dose of prasugrel in low body weight (LBW) patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg dose in higher body weight (HBW) patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
72 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight Aspirin-Treated Subjects With Stable Coronary Artery Disease
Study Start Date
:
Mar 1, 2010
Actual Primary Completion Date
:
Aug 1, 2011
Actual Study Completion Date
:
Aug 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 5 mg prasugrel
|
Drug: prasugrel
Administered orally, daily for 12 days
Other Names:
|
| Active Comparator: 10 mg prasugrel
|
Drug: prasugrel
Administered orally, daily for 12 days
Other Names:
|
| Active Comparator: 75 mg clopidogrel
|
Drug: clopidogrel
Administered orally, daily for 12 days
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1) [Baseline, Day 12]
MPA to 20 micromolar (μM) ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.
Secondary Outcome Measures
- Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy [Baseline, Day 12]
VASP phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition and were used to compare prasugrel versus clopidogrel, in low body weight (LBW) participants compared to higher body weight (HBW) participants. PRI was calculated by VASP. The PRI indicates the level of P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12 receptor thus stronger platelet inhibition, whereas a higher PRI reflects weaker inhibition of P2Y12 receptor and weaker platelet inhibition.
- Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy [Baseline, Day 12]
The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in PRU. PRU indicates the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of rate and extent of platelet aggregation in an adenosine phosphate (ADP)-containing channel of the device. A lower PRU reflects stronger inhibition of platelet aggregation, whereas a higher PRU reflects weaker inhibition of platelet aggregation.
- Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC) [baseline (pre-dose) up to 4 hours post-dose]
A pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing MPA (LTA) and AUC was conducted as originally intended, however the graphic output is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.
- Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy [Baseline , Day 12]
MPA to 20 micromolar (μM) adenosine diphosphate (ADP) was assessed by LTA, an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects with a history of stable coronary artery disease who are not currently indicated for treatment with a thienopyridine (that is, prasugrel, clopidogrel, or ticlopidine)
-
Provision of written informed consent
-
For women of child-bearing potential only (that is, women who are not surgically or chemically sterilised and who are between menarche and 1 year post menopause), test negative for pregnancy (based on a urine or serum pregnancy test to be performed before randomisation) and agree to use a reliable method of birth control during the study
Exclusion Criteria:
-
Unstable coronary artery disease
-
Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft Surgery (CABG) within the previous 90 days
-
History of refractory ventricular arrhythmias within the last 6 months; an implanted defibrillator device; congestive heart failure within 6 months prior to screening; major surgery, or severe trauma, fracture or organ biopsy within 3 months prior to enrollment
-
Any planned surgical procedure or any coronary revascularisation (surgical or percutaneous) planned within 60 days following randomisation
-
Any known contraindication to treatment with an antiplatelet agent
-
Significant hypertension at the time of screening or randomisation
-
Clinically significant out-of-range values for platelet count or haemoglobin at screening, in the investigator's opinion, or results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the study population, as determined by the investigator
-
Prior history or presence of significant bleeding disorders, abnormal bleeding tendency, or personal history of coagulation or bleeding disorders.
-
Prior history or clinical suspicion of cerebral vascular malformations, intracranial neoplasm, Transient Ischemic Attack (TIA) or stroke.
-
Prior history of thrombocytopenia or thrombocytosis
-
Use of antiplatelet agents (besides aspirin) within 10 days prior to screening; the use (or planned use) of heparin, oral anticoagulants, or fibrinolytic agents within 30 days of screening; or subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jacksonville | Florida | United States | 32209 |
| 2 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cincinnati | Ohio | United States | 45212 |
| 3 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dublin | Ireland | 9 | |
| 4 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nieuwegein | Netherlands | 3435 CM | |
| 5 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lund | Sweden | 22185 | |
| 6 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Uppsala | Sweden | 75185 |
Sponsors and Collaborators
- Eli Lilly and Company
- Daiichi Sankyo Co., Ltd.
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01107925
Other Study ID Numbers:
- 12921
- H7T-MC-TADI
First Posted:
Apr 21, 2010
Last Update Posted:
Aug 30, 2012
Last Verified:
Jul 1, 2012
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 5 mg Prasugrel (LBW) | 10 mg Prasugrel (LBW) | 75 mg Clopidogrel (LBW) | 5 mg Prasugrel (HBW) | 10 mg Prasugrel (HBW) | 75 mg Clopidogrel (HBW) |
|---|---|---|---|---|---|---|
| Arm/Group Description | During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2. | Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3. | Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods. | Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. |
| Period Title: Period 1-Randomization up Through Day 12 | ||||||
| STARTED | 34 | 0 | 0 | 0 | 38 | 0 |
| Took at Least 1 Dose of Study Drug | 34 | 0 | 0 | 0 | 38 | 0 |
| COMPLETED | 33 | 0 | 0 | 0 | 37 | 0 |
| NOT COMPLETED | 1 | 0 | 0 | 0 | 1 | 0 |
| Period Title: Period 1-Randomization up Through Day 12 | ||||||
| STARTED | 0 | 16 | 17 | 20 | 0 | 17 |
| Took at Least 1 Dose of Study Drug | 0 | 16 | 17 | 20 | 0 | 17 |
| COMPLETED | 0 | 15 | 17 | 20 | 0 | 16 |
| NOT COMPLETED | 0 | 1 | 0 | 0 | 0 | 1 |
| Period Title: Period 1-Randomization up Through Day 12 | ||||||
| STARTED | 0 | 17 | 15 | 16 | 0 | 20 |
| Took at Least 1 Dose of Study Drug | 0 | 17 | 15 | 16 | 0 | 20 |
| COMPLETED | 0 | 17 | 15 | 16 | 0 | 20 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW) | Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW) | Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW) | Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants in the low body weight (LBW; <60 kilograms [kg]) group received 5 milligrams (mg) of Prasugrel (Pras) during Study Period 1, followed by 10 mg Pras in Study Period 2, followed by 75 mg clopidogrel (Clop) in Study Period 3. | Participants in the LBW group received 5 mg Pras during Study Period 1, followed by 75 mg Clop in Study Period 2, and 10 mg Pras in Study Period 3. | Participants in the higher body weight (HBW; ≥60 kg) group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3. | Participants in the HBW group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3. | Total of all reporting groups |
| Overall Participants | 17 | 17 | 21 | 17 | 72 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
61.3
(8.07)
|
63.2
(7.65)
|
61.4
(9.57)
|
64.6
(6.91)
|
62.6
(8.15)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
15
88.2%
|
14
82.4%
|
7
33.3%
|
5
29.4%
|
41
56.9%
|
| Male |
2
11.8%
|
3
17.6%
|
14
66.7%
|
12
70.6%
|
31
43.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
10
58.8%
|
8
47.1%
|
11
52.4%
|
8
47.1%
|
37
51.4%
|
| Unknown or Not Reported |
7
41.2%
|
9
52.9%
|
10
47.6%
|
9
52.9%
|
35
48.6%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
5.9%
|
0
0%
|
0
0%
|
1
1.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
1
4.8%
|
3
17.6%
|
4
5.6%
|
| White |
17
100%
|
16
94.1%
|
20
95.2%
|
14
82.4%
|
67
93.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
0
0%
|
0
0%
|
2
9.5%
|
2
11.8%
|
4
5.6%
|
| Ireland |
2
11.8%
|
2
11.8%
|
8
38.1%
|
6
35.3%
|
18
25%
|
| Netherlands |
9
52.9%
|
8
47.1%
|
5
23.8%
|
5
29.4%
|
27
37.5%
|
| Sweden |
6
35.3%
|
7
41.2%
|
6
28.6%
|
4
23.5%
|
23
31.9%
|
| Weight (kilograms (kg)) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [kilograms (kg)] |
56.06
(4.575)
|
56.78
(2.619)
|
83.60
(17.146)
|
85.96
(11.898)
|
71.33
(17.980)
|
| Tobacco Use Status (participants) [Number] | |||||
| Tobacco Use Yes |
7
41.2%
|
8
47.1%
|
5
23.8%
|
4
23.5%
|
24
33.3%
|
| Tobacco Use No |
10
58.8%
|
9
52.9%
|
16
76.2%
|
13
76.5%
|
48
66.7%
|
Outcome Measures
| Title | Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1) |
|---|---|
| Description | MPA to 20 micromolar (μM) ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition. |
| Time Frame | Baseline, Day 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary intent-to-treat (ITT) pharmacodynamic (PD) population: all randomized participants who continued in the study through Day 12, and had at least 1 evaluable PD assessment at Day 12. Participants were analyzed based on the treatment group they were randomized to irrespective to the treatment they received. |
| Arm/Group Title | Prasugrel 5 mg (LBW) | Prasugrel 10 mg (HBW) |
|---|---|---|
| Arm/Group Description | Participants in the low body weight (LBW; <60 kilograms [kg]) group received the 5-milligram (mg) prasugrel dose in Study Period 1. | Participants in the higher body weight (HBW; ≥60 kg) group received the 10-mg prasugrel dose in Study Period 1. |
| Measure Participants | 33 | 37 |
| Baseline |
75.00
|
76.40
|
| Day 12 (n=32, 37) |
47.00
|
47.00
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 5 mg (LBW), Prasugrel 10 mg (HBW) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Difference in median MPA in response to 20 μM ADP in LBW participants who received 5 mg prasugrel to the 75th percentile of MPA response to 20 μM ADP in HBW participants who received10 mg prasugrel at the end of Study Period 1 (Baseline through Day 12) was estimated from the observed data. | |
| Statistical Test of Hypothesis | p-Value | 0.526 |
| Comments | ||
| Method | bootstrap (to determine 95% CI) | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Estimate of the difference |
| Estimated Value | -10.10 | |
| Confidence Interval |
(2-Sided) 95% -23.40 to 0.20 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Estimate of the difference = [median (low body weight) - Q3 (higher body weight)] | |
| Title | Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy |
|---|---|
| Description | VASP phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition and were used to compare prasugrel versus clopidogrel, in low body weight (LBW) participants compared to higher body weight (HBW) participants. PRI was calculated by VASP. The PRI indicates the level of P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12 receptor thus stronger platelet inhibition, whereas a higher PRI reflects weaker inhibition of P2Y12 receptor and weaker platelet inhibition. |
| Time Frame | Baseline, Day 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment. |
| Arm/Group Title | 5 mg Prasugrel (LBW) | 10 mg Prasugrel (LBW) | 75 mg Clopidogrel (LBW) | 5 mg Prasugrel (HBW) | 10 mg Prasugrel (HBW) | 75 mg Clopidogrel (HBW) |
|---|---|---|---|---|---|---|
| Arm/Group Description | During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2. | Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3. | Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods. | Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose either during Study Period 2 or Study Period 3. |
| Measure Participants | 33 | 32 | 32 | 36 | 37 | 36 |
| Baseline |
86.57
(4.44)
|
86.44
(4.45)
|
86.44
(4.45)
|
86.77
(3.42)
|
86.76
(3.37)
|
86.77
(3.42)
|
| Day 12 (n=32,31,30,32,36,34) |
33.54
(15.77)
|
15.09
(11.71)
|
39.01
(17.49)
|
56.87
(15.47)
|
27.79
(18.13)
|
56.35
(18.33)
|
| Title | Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy |
|---|---|
| Description | The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in PRU. PRU indicates the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of rate and extent of platelet aggregation in an adenosine phosphate (ADP)-containing channel of the device. A lower PRU reflects stronger inhibition of platelet aggregation, whereas a higher PRU reflects weaker inhibition of platelet aggregation. |
| Time Frame | Baseline, Day 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment. |
| Arm/Group Title | 5 mg Prasugrel (LBW) | 10 mg Prasugrel (LBW) | 75 mg Clopidogrel (LBW) | 5 mg Prasugrel (HBW) | 10 mg Prasugrel (HBW) | 75 mg Clopidogrel (HBW) |
|---|---|---|---|---|---|---|
| Arm/Group Description | During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; (<60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2. | Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3. | Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods. | Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose during Study Period 2 or Study Period 3. |
| Measure Participants | 33 | 32 | 32 | 36 | 37 | 36 |
| Baseline |
317.9
(46.10)
|
315.3
(44.26)
|
315.3
(44.26)
|
312.8
(43.01)
|
311.0
(43.76)
|
312.8
(43.01)
|
| Day 12 (n=32,31,32,35,34,34) |
129.5
(62.14)
|
55.9
(38.08)
|
151.7
(57.46)
|
193.9
(74.09)
|
102.1
(69.49)
|
207.0
(67.62)
|
| Title | Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC) |
|---|---|
| Description | A pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing MPA (LTA) and AUC was conducted as originally intended, however the graphic output is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances. |
| Time Frame | baseline (pre-dose) up to 4 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available PK sample data from all treated participants who contributed complete PK profiles. |
| Arm/Group Title | Prasugrel 5 mg (LBW) | Prasugrel 10 mg (LBW) | Clopidogrel 75 mg (LBW) | Prasugrel 5 mg (HBW) | Prasugrel 10 mg (HBW) | Clopidogrel 75 mg (HBW) |
|---|---|---|---|---|---|---|
| Arm/Group Description | During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2. | Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods. | Participants in the HBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. |
| Measure Participants | 34 | 33 | 30 | 36 | 38 | 37 |
| Measure Participant Profiles | 34 | 50 | 45 | 52 | 38 | 57 |
| Geometric Mean (Geometric Coefficient of Variation) [nanogram•hour/milliliter (ng•hr/mL)] |
28.9
(37)
|
59.3
(40)
|
18.4
(38)
|
19.4
(46)
|
46.7
(44)
|
12.7
(60)
|
| Title | Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy |
|---|---|
| Description | MPA to 20 micromolar (μM) adenosine diphosphate (ADP) was assessed by LTA, an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition. |
| Time Frame | Baseline , Day 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment. |
| Arm/Group Title | 5 mg Prasugrel (LBW) | 10 mg Prasugrel (LBW) | 75 mg Clopidogrel (LBW) | 5 mg Prasugrel (HBW) | 10 mg Prasugrel (HBW) | 75 mg Clopidogrel (HBW) |
|---|---|---|---|---|---|---|
| Arm/Group Description | During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2. | Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | Participants in the LBW treatment sequence in Period 1 (on 5 mg prasugrel) were switched to either the 10-mg prasugrel or the 75-mg clopidogrel dose for Period 2 or Period 3. | Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | During Study Period 1, participants in the (HBW; ≥ 60 kg) treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods. | Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either 5-mg prasugrel or the 75-mg clopidogrel dose during Study Period 2 or Study Period 3. |
| Measure Participants | 33 | 32 | 32 | 36 | 37 | 36 |
| Baseline |
76.27
(9.49)
|
76.20
(9.63)
|
76.20
(9.63)
|
77.63
(12.29)
|
77.93
(12.27)
|
77.63
(12.29)
|
| Day 12 ( n= 32,32,31,35,37,35) |
48.10
(13.89)
|
38.11
(14.17)
|
51.41
(13.56)
|
61.90
(18.93)
|
47.92
(15.18)
|
65.28
(17.83)
|
Adverse Events
| Time Frame | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | 5 mg Prasugrel (LBW) | 10 mg Prasugrel (LBW) | 75 mg Clopidogrel (LBW) | 5 mg Prasugrel (HBW) | 10 mg Prasugrel (HBW) | 75 mg Clopidogrel (HBW) | ||||||
| Arm/Group Description | During Study Period 1, participants received 5 milligrams (mg) prasugrel for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2. | Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3. | Participants in the higher body weight (HBW; ≥ 60 mg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods. | Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. | ||||||
All Cause Mortality |
||||||||||||
| 5 mg Prasugrel (LBW) | 10 mg Prasugrel (LBW) | 75 mg Clopidogrel (LBW) | 5 mg Prasugrel (HBW) | 10 mg Prasugrel (HBW) | 75 mg Clopidogrel (HBW) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| 5 mg Prasugrel (LBW) | 10 mg Prasugrel (LBW) | 75 mg Clopidogrel (LBW) | 5 mg Prasugrel (HBW) | 10 mg Prasugrel (HBW) | 75 mg Clopidogrel (HBW) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/34 (0%) | 1/33 (3%) | 0/32 (0%) | 0/36 (0%) | 0/38 (0%) | 0/37 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Subarachnoid haemorrhage | 0/34 (0%) | 0 | 1/33 (3%) | 1 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| 5 mg Prasugrel (LBW) | 10 mg Prasugrel (LBW) | 75 mg Clopidogrel (LBW) | 5 mg Prasugrel (HBW) | 10 mg Prasugrel (HBW) | 75 mg Clopidogrel (HBW) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 20/34 (58.8%) | 21/33 (63.6%) | 14/32 (43.8%) | 10/36 (27.8%) | 12/38 (31.6%) | 14/37 (37.8%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 1/36 (2.8%) | 1 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Macrocytosis | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Spontaneous haematoma | 0/34 (0%) | 0 | 1/33 (3%) | 2 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Thrombocytopenia | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Cardiac disorders | ||||||||||||
| Atrioventricular block first degree | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 1/37 (2.7%) | 1 |
| Palpitations | 1/34 (2.9%) | 2 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Eye disorders | ||||||||||||
| Conjunctival haemorrhage | 0/34 (0%) | 0 | 1/33 (3%) | 1 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Abdominal discomfort | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 1/38 (2.6%) | 1 | 0/37 (0%) | 0 |
| Abdominal pain upper | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 1/38 (2.6%) | 1 | 0/37 (0%) | 0 |
| Constipation | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Diarrhoea | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Eructation | 0/34 (0%) | 0 | 1/33 (3%) | 1 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Haematochezia | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Nausea | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 2/38 (5.3%) | 3 | 2/37 (5.4%) | 2 |
| Vomiting | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| General disorders | ||||||||||||
| Chest pain | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 | 1/32 (3.1%) | 3 | 1/36 (2.8%) | 1 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Fatigue | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Feeling abnormal | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Influenza like illness | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 1/36 (2.8%) | 1 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Obstruction | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Pyrexia | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Nasopharyngitis | 3/34 (8.8%) | 3 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Rhinitis | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Sinusitis | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||
| Contusion | 6/34 (17.6%) | 6 | 9/33 (27.3%) | 9 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 3/38 (7.9%) | 3 | 2/37 (5.4%) | 2 |
| Limb injury | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 1/38 (2.6%) | 1 | 0/37 (0%) | 0 |
| Periorbital haematoma | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 1/37 (2.7%) | 1 |
| Traumatic haematoma | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 | 2/32 (6.3%) | 3 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Wound | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 1/37 (2.7%) | 1 |
| Wound haemorrhage | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Investigations | ||||||||||||
| Blood creatine phosphokinase increased | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 1/38 (2.6%) | 1 | 0/37 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Hyperglycaemia | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 1/38 (2.6%) | 1 | 0/37 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 1/37 (2.7%) | 2 |
| Back pain | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Exostosis | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 1/38 (2.6%) | 1 | 0/37 (0%) | 0 |
| Joint swelling | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Muscle spasms | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 1/36 (2.8%) | 2 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Musculoskeletal discomfort | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 1/36 (2.8%) | 1 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Myalgia | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Dizziness | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 1/38 (2.6%) | 1 | 0/37 (0%) | 0 |
| Dizziness postural | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 1/37 (2.7%) | 1 |
| Formication | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Headache | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 2 | 1/36 (2.8%) | 1 | 2/38 (5.3%) | 2 | 1/37 (2.7%) | 1 |
| Paraesthesia | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 1/38 (2.6%) | 1 | 0/37 (0%) | 0 |
| Presyncope | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 1/37 (2.7%) | 1 |
| Renal and urinary disorders | ||||||||||||
| Haematuria | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||
| Menorrhagia | 0/34 (0%) | 0 | 1/33 (3%) | 1 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Asthma | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Chronic respiratory disease | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Cough | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Dyspnoea | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Epistaxis | 1/34 (2.9%) | 2 | 2/33 (6.1%) | 3 | 1/32 (3.1%) | 1 | 1/36 (2.8%) | 1 | 1/38 (2.6%) | 1 | 2/37 (5.4%) | 2 |
| Nasal congestion | 0/34 (0%) | 0 | 1/33 (3%) | 1 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| Hyperhidrosis | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 1/36 (2.8%) | 1 | 1/38 (2.6%) | 1 | 0/37 (0%) | 0 |
| Pruritus | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 1/36 (2.8%) | 1 | 1/38 (2.6%) | 1 | 0/37 (0%) | 0 |
| Rash | 0/34 (0%) | 0 | 1/33 (3%) | 1 | 1/32 (3.1%) | 1 | 0/36 (0%) | 0 | 1/38 (2.6%) | 1 | 0/37 (0%) | 0 |
| Vascular disorders | ||||||||||||
| Haematoma | 3/34 (8.8%) | 3 | 5/33 (15.2%) | 7 | 3/32 (9.4%) | 7 | 5/36 (13.9%) | 7 | 3/38 (7.9%) | 4 | 1/37 (2.7%) | 3 |
| Hypotension | 0/34 (0%) | 0 | 0/33 (0%) | 0 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 1/37 (2.7%) | 1 |
| Intermittent claudication | 0/34 (0%) | 0 | 1/33 (3%) | 1 | 0/32 (0%) | 0 | 0/36 (0%) | 0 | 0/38 (0%) | 0 | 0/37 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01107925
Other Study ID Numbers:
- 12921
- H7T-MC-TADI
First Posted:
Apr 21, 2010
Last Update Posted:
Aug 30, 2012
Last Verified:
Jul 1, 2012