SWAP: Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00356135
Collaborator
Daiichi Sankyo, Inc. (Industry)
139
9
3
29
15.4
0.5
Study Details
Study Description
Brief Summary
This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
139 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Pharmacodynamic Comparison of Prasugrel (LY640315) Versus Clopidogrel in Subjects With Acute Coronary Syndrome Who Are Receiving Clopidogrel
Study Start Date
:
Jul 1, 2006
Actual Primary Completion Date
:
Dec 1, 2008
Actual Study Completion Date
:
Dec 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prasugrel 10/10 mg Open label (lead-in) dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. |
Drug: prasugrel 10 mg
10 mg tablet taken orally
Other Names:
Drug: clopidogrel
75 mg tablet taken orally
Other Names:
Drug: prasugrel placebo
oral, as blinding mechanism.
Drug: clopidogrel placebo
oral, as blinding mechanism
|
| Experimental: Clopidogrel 75/75 mg Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. |
Drug: clopidogrel
75 mg tablet taken orally
Other Names:
Drug: prasugrel placebo
oral, as blinding mechanism.
|
| Experimental: Prasugrel 60/10 mg Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. |
Drug: prasugrel 10 mg
10 mg tablet taken orally
Other Names:
Drug: clopidogrel
75 mg tablet taken orally
Other Names:
Drug: prasugrel 60 mg
60 mg (six 10-mg tablets) taken orally
Other Names:
Drug: clopidogrel placebo
oral, as blinding mechanism
|
Outcome Measures
Primary Outcome Measures
- Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP) [1 week after first dose of randomized study drug]
Maximum platelet aggregation (MPA) to 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).
Secondary Outcome Measures
- Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks [2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug]
Maximum platelet aggregation (MPA) to 5 and 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).
- Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event [End of 14 day open label]
Data provided are the MPA to 20 micromolar ADP while taking clopidogrel (measurement taken at end of the 14 day open label phase) grouped by subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event.
- Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks [2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug]
Residual platelet aggregation after the addition 5 and 20 micromolar ADP as measured with light transmittance aggregometry (LTA).
- Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week [1 week after randomized study drug]
Correlation Coefficient comparing the Accumetrics VerifyNow™ P2Y12 device with light transmittance aggregometry (LTA) for monitoring platelet aggregation.
- Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria [End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug]
Bleeding events were classified as Major Bleeding, Minor Bleeding, or Insignificant according to TIMI criteria. Major Bleeding: any intracranial hemorrhage OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Insignificant Bleeding: any bleeding event that does not meet criteria for a Major or Minor Bleed.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Present with a recent history of an ACS event based on the disease diagnostic criteria between 30 and 330 days prior to enrollment, and who state that they are supposed to be taking daily aspirin and maintenance dose 75-mg clopidogrel.
-
Are of a legal age (and at least 18 years of age but less than 75 years of age) and competent mental condition to provide written informed consent before entering the study.
Exclusion Criteria:
-
Left main coronary artery stent or left anterior descending (LAD) bifurcation stent.
-
Have any form of coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) planned to occur during the study (from signing consent through the final visit).
-
Have undergone CABG or PCI within 30 days of entry into the study.
-
Receiving or will receive oral anticoagulation or other antiplatelet therapy (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study.
-
Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or are anticipated to require daily treatment with NSAIDs during the study.
-
Have any of the following: history of ischemic or hemorrhagic stroke intracranial neoplasm, arteriovenous malformation, or aneurysm history of transient ischemic attack (TIA), have a body weight less than 60 kilograms (kg).
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) Monday-Friday from 9:00 AM to 5:00 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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Baltimore | Maryland | United States | 21215 |
| 3 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Worcester | Massachusetts | United States | 01655 |
| 4 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Ann Arbor | Michigan | United States | 48109 |
| 5 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Cincinnati | Ohio | United States | 45219 |
| 6 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Columbus | Ohio | United States | 43210 |
| 7 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Oklahoma City | Oklahoma | United States | 73104 |
| 8 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Rapid City | South Dakota | United States | 57701 |
| 9 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Houston | Texas | United States | 77024 |
Sponsors and Collaborators
- Eli Lilly and Company
- Daiichi Sankyo, Inc.
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 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:
,
,
ClinicalTrials.gov Identifier:
NCT00356135
Other Study ID Numbers:
- 10631
- H7T-MC-TABM
First Posted:
Jul 25, 2006
Last Update Posted:
Nov 3, 2010
Last Verified:
Oct 1, 2010
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 30-330 days after acute coronary syndrome event, patients participated in 2 week open-label clopidogrel phase. Patients were then randomized to either 22-26 hour loading doses of: 60-mg prasugrel, 10-mg prasugrel, or 75-mg clopidogrel, then continued 2-week maintenance phase of 10-mg prasugrel, 10-mg prasugrel, or 75-mg clopidogrel, respectively. |
| Arm/Group Title | Prasgurel 10/10 mg | Clopidogrel 75/75 mg | Prasugrel 60/10 mg |
|---|---|---|---|
| Arm/Group Description | Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. |
| Period Title: Overall Study | |||
| STARTED | 47 | 48 | 44 |
| COMPLETED | 43 | 46 | 39 |
| NOT COMPLETED | 4 | 2 | 5 |
Baseline Characteristics
| Arm/Group Title | Prasugrel 10/10 mg | Clopidogrel 75/75 mg | Prasugrel 60/10 mg | Total |
|---|---|---|---|---|
| Arm/Group Description | Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. | Total of all reporting groups |
| Overall Participants | 47 | 48 | 44 | 139 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
57.6
(8.18)
|
56.9
(8.93)
|
58.7
(9.16)
|
57.7
(8.73)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
12
25.5%
|
18
37.5%
|
15
34.1%
|
45
32.4%
|
| Male |
35
74.5%
|
30
62.5%
|
29
65.9%
|
94
67.6%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||
| Caucasian |
39
83%
|
30
62.5%
|
37
84.1%
|
106
76.3%
|
| African |
7
14.9%
|
13
27.1%
|
6
13.6%
|
26
18.7%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Other |
1
2.1%
|
5
10.4%
|
1
2.3%
|
7
5%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
47
100%
|
48
100%
|
44
100%
|
139
100%
|
Outcome Measures
| Title | Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP) |
|---|---|
| Description | Maximum platelet aggregation (MPA) to 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA). |
| Time Frame | 1 week after first dose of randomized study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis population was the pharmacodynamic (PD) population which included all randomized participants who had blood draws for MPA at 1 week after randomization who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA. |
| Arm/Group Title | Prasugrel 10/10 mg | Clopidogrel 75/75 mg | Prasugrel 60/10 mg |
|---|---|---|---|
| Arm/Group Description | Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. |
| Measure Participants | 34 | 31 | 30 |
| Least Squares Mean (Standard Error) [percent maximum platelet aggregation (%)] |
41.1
(1.99)
|
55.0
(2.09)
|
41.0
(2.00)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | Treatment and study sites are fixed effects and MPA right before the randomization treatment period is a covariate in the model. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -13.91 | |
| Confidence Interval |
() 95% -19.10 to -8.73 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Mean Difference is for Prasugrel 10/10 mg arm minus Clopidogrel 75/75 mg arm. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| 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 (Final Values) |
| Estimated Value | -13.98 | |
| Confidence Interval |
() 95% -19.26 to -8.71 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks |
|---|---|
| Description | Maximum platelet aggregation (MPA) to 5 and 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA). |
| Time Frame | 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA. |
| Arm/Group Title | Prasugrel 10/10 mg | Clopidogrel 75/75 mg | Prasugrel 60/10 mg |
|---|---|---|---|
| Arm/Group Description | Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. |
| Measure Participants | 36 | 33 | 31 |
| 2 Hour (20 uM ADP) |
49.46
(21.243)
|
48.07
(17.728)
|
26.65
(10.875)
|
| 24 Hour (20 uM ADP) |
52.29
(16.511)
|
53.80
(14.504)
|
27.36
(10.812)
|
| 1 Week (20 uM ADP) |
42.95
(14.963)
|
53.80
(14.878)
|
40.64
(10.182)
|
| 2 Week (20 uM ADP) |
40.84
(13.359)
|
52.25
(16.856)
|
38.61
(13.373)
|
| 2 Hour (5 uM ADP) |
37.87
(16.547)
|
37.25
(12.579)
|
19.97
(11.263)
|
| 24 Hour (5 uM ADP) |
38.84
(14.841)
|
40.88
(14.540)
|
20.94
(11.476)
|
| 1 Week (5 uM ADP) |
32.44
(11.739)
|
41.94
(14.436)
|
31.45
(11.446)
|
| 2 Week (5 uM ADP) |
30.18
(11.444)
|
41.05
(13.570)
|
28.64
(13.534)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4055 |
| Comments | P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -2.4 | |
| Confidence Interval |
(2-Sided) 95% -8.22 to 3.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -23 | |
| Confidence Interval |
(2-Sided) 95% -29.30 to -17.51 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0680 |
| Comments | P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -4.2 | |
| Confidence Interval |
(2-Sided) 95% -8.82 to 0.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | Comparison of MPA to 20 uM ADP at 24 hours | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -29 | |
| Confidence Interval |
(2-Sided) 95% -33.20 to -23.94 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -15 | |
| Confidence Interval |
(2-Sided) 95% -19.96 to -9.65 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -15 | |
| Confidence Interval |
(2-Sided) 95% -19.87 to -9.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -15 | |
| Confidence Interval |
(2-Sided) 95% -20.30 to -9.22 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -15 | |
| Confidence Interval |
(2-Sided) 95% -20.59 to -9.22 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5501 |
| Comments | P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.4 | |
| Confidence Interval |
(2-Sided) 95% -5.85 to 3.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -17 | |
| Confidence Interval |
(2-Sided) 95% -21.55 to -12.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0752 |
| Comments | P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -4.1 | |
| Confidence Interval |
(2-Sided) 95% -8.58 to 0.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -20 | |
| Confidence Interval |
(2-Sided) 95% -24.81 to -15.64 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -12 | |
| Confidence Interval |
(2-Sided) 95% -17.21 to -7.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -11 | |
| Confidence Interval |
(2-Sided) 95% -15.79 to -5.79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -13 | |
| Confidence Interval |
(2-Sided) 95% -17.41 to -7.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -12 | |
| Confidence Interval |
(2-Sided) 95% -16.80 to -6.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
| Title | Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event |
|---|---|
| Description | Data provided are the MPA to 20 micromolar ADP while taking clopidogrel (measurement taken at end of the 14 day open label phase) grouped by subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event. |
| Time Frame | End of 14 day open label |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA. Grouped according to clopidogrel use at time of ACS event and no clopidogrel use at time of ACS event. |
| Arm/Group Title | Clopidogrel Use | No Clopidogrel Use |
|---|---|---|
| Arm/Group Description | Patients with clopidogrel use at the time of qualifying ACS event. | Patients with no clopidogrel use at the time of qualifying ACS event. |
| Measure Participants | 20 | 75 |
| Mean (Standard Deviation) [percent maximum platelet aggregation (%)] |
60.73
(18.729)
|
55.53
(14.356)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | The mean of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the mean MPA of patients not using clopidogrel at this time. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1824 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | The variance of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the variance of MPA for patients not using clopidogrel at this time. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1101 |
| Comments | ||
| Method | F-test | |
| Comments | ||
| Title | Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks |
|---|---|
| Description | Residual platelet aggregation after the addition 5 and 20 micromolar ADP as measured with light transmittance aggregometry (LTA). |
| Time Frame | 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA. |
| Arm/Group Title | Prasugrel 10/10 mg | Clopidogrel 75/75 mg | Prasugrel 60/10 mg |
|---|---|---|---|
| Arm/Group Description | Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. |
| Measure Participants | 36 | 33 | 31 |
| 2 Hour (20 uM ADP) |
32.06
(24.462)
|
28.21
(21.792)
|
5.10
(7.814)
|
| 24 Hour (20 uM ADP) |
32.97
(21.858)
|
35.16
(19.379)
|
4.70
(5.688)
|
| 1 Week (20 uM ADP) |
22.92
(17.961)
|
34.45
(21.752)
|
17.94
(12.961)
|
| 2 Week (20 uM ADP) |
18.89
(14.401)
|
34.56
(19.515)
|
15.17
(15.127)
|
| 2 Hour (5 uM ADP) |
18.83
(17.574)
|
14.84
(12.767)
|
4.17
(4.878)
|
| 24 Hour (5 uM ADP) |
19.18
(16.448)
|
19.66
(14.672)
|
4.45
(4.545)
|
| 1 Week (5 uM ADP) |
11.11
(10.325)
|
21.57
(18.829)
|
9.94
(10.370)
|
| 2 Week (5 uM ADP) |
10.03
(9.247)
|
19.28
(14.824)
|
9.43
(8.621)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3466 |
| Comments | P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -3.1 | |
| Confidence Interval |
(2-Sided) 95% -9.50 to 3.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -27 | |
| Confidence Interval |
(2-Sided) 95% -33.40 to -20.33 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0127 |
| Comments | P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -7.3 | |
| Confidence Interval |
(2-Sided) 95% -13.04 to -1.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -34 | |
| Confidence Interval |
(2-Sided) 95% -39.99 to -28.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -18 | |
| Confidence Interval |
(2-Sided) 95% -25.58 to -11.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -20 | |
| Confidence Interval |
(2-Sided) 95% -27.09 to -12.26 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -22 | |
| Confidence Interval |
(2-Sided) 95% -28.42 to -14.77 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -23 | |
| Confidence Interval |
(2-Sided) 95% -29.61 to -15.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4954 |
| Comments | P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 1.6 | |
| Confidence Interval |
(2-Sided) 95% -3.11 to 6.38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -11 | |
| Confidence Interval |
(2-Sided) 95% -15.92 to -6.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1971 |
| Comments | P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -3.3 | |
| Confidence Interval |
(2-Sided) 95% -8.31 to 1.74 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -16 | |
| Confidence Interval |
(2-Sided) 95% -20.98 to -10.75 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -13 | |
| Confidence Interval |
(2-Sided) 95% -18.81 to -7.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -12 | |
| Confidence Interval |
(2-Sided) 95% -17.91 to -6.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg, Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -11 | |
| Confidence Interval |
(2-Sided) 95% -15.64 to -6.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg. | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg, Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect. | |
| Method | Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -9.9 | |
| Confidence Interval |
(2-Sided) 95% -14.67 to -5.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg. | |
| Title | Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week |
|---|---|
| Description | Correlation Coefficient comparing the Accumetrics VerifyNow™ P2Y12 device with light transmittance aggregometry (LTA) for monitoring platelet aggregation. |
| Time Frame | 1 week after randomized study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA. |
| Arm/Group Title | Prasugrel 10/10 mg | Clopidogrel 75/75 mg | Prasugrel 60/10 mg |
|---|---|---|---|
| Arm/Group Description | Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. |
| Measure Participants | 36 | 33 | 31 |
| MPA (20 uM ADP) at 1 week |
0.564
|
0.426
|
0.439
|
| RPA (20 uM ADP) at 1 week |
0.640
|
0.425
|
0.547
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0005 |
| Comments | P-value for MPA (20 uM ADP) at 1 week. | |
| Method | Pearson Correlation Coefficient | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 10/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value for RPA (20 uM ADP) at 1 week. | |
| Method | Pearson Correlation Coefficient | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0150 |
| Comments | P-value for MPA (20 uM ADP) at 1 week. | |
| Method | Pearson Correlation Coefficient | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Clopidogrel 75/75 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0152 |
| Comments | P-value for RPA (20 uM ADP) at 1 week. | |
| Method | Pearson Correlation Coefficient | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0153 |
| Comments | P-value for MPA (20 uM ADP) at 1 week. | |
| Method | Pearson Correlation Coefficient | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Prasugrel 60/10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0018 |
| Comments | P-value for RPA (20 uM ADP) at 1 week. | |
| Method | Pearson Correlation Coefficient | |
| Comments | ||
| Title | Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria |
|---|---|
| Description | Bleeding events were classified as Major Bleeding, Minor Bleeding, or Insignificant according to TIMI criteria. Major Bleeding: any intracranial hemorrhage OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Insignificant Bleeding: any bleeding event that does not meet criteria for a Major or Minor Bleed. |
| Time Frame | End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population - all randomized participants. |
| Arm/Group Title | Prasugrel 10/10 mg | Clopidogrel 75/75 mg | Prasugrel 60/10 mg |
|---|---|---|---|
| Arm/Group Description | Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. |
| Measure Participants | 47 | 48 | 44 |
| Any Bleeding at Any Time During Randomized Period |
4
8.5%
|
6
12.5%
|
6
13.6%
|
| Baseline: Any Bleeding |
0
0%
|
3
6.3%
|
1
2.3%
|
| Baseline: Insignificant Bleeding |
0
0%
|
3
6.3%
|
1
2.3%
|
| Baseline: Minor Bleeding |
0
0%
|
0
0%
|
0
0%
|
| Baseline: Major Bleeding |
0
0%
|
0
0%
|
0
0%
|
| Hour 24: Any Bleeding |
0
0%
|
0
0%
|
1
2.3%
|
| Hour 24: Insignificant Bleeding |
0
0%
|
0
0%
|
1
2.3%
|
| Hour 24: Minor Bleeding |
0
0%
|
0
0%
|
0
0%
|
| Hour 24: Major Bleeding |
0
0%
|
0
0%
|
0
0%
|
| Day 7: Any Bleeding |
2
4.3%
|
2
4.2%
|
3
6.8%
|
| Day 7: Insignificant Bleeding |
2
4.3%
|
2
4.2%
|
3
6.8%
|
| Day 7: Minor Bleeding |
0
0%
|
0
0%
|
0
0%
|
| Day 7: Major Bleeding |
0
0%
|
0
0%
|
0
0%
|
| Day 14: Any Bleeding |
2
4.3%
|
4
8.3%
|
2
4.5%
|
| Day 14: Insignificant Bleeding |
2
4.3%
|
4
8.3%
|
2
4.5%
|
| Day 14: Minor Bleeding |
0
0%
|
0
0%
|
0
0%
|
| Day 14: Major Bleeding |
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Prasgurel 10/10 mg | Clopidogrel 75/75 mg | Prasugrel 60/10 mg | |||
| Arm/Group Description | Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. | Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. | |||
All Cause Mortality |
||||||
| Prasgurel 10/10 mg | Clopidogrel 75/75 mg | Prasugrel 60/10 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Prasgurel 10/10 mg | Clopidogrel 75/75 mg | Prasugrel 60/10 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/47 (6.4%) | 0/48 (0%) | 0/44 (0%) | |||
| General disorders | ||||||
| Chest pain | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| In-stent coronary artery restenosis | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Nervous system disorders | ||||||
| Syncope | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Prasgurel 10/10 mg | Clopidogrel 75/75 mg | Prasugrel 60/10 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/47 (34%) | 25/48 (52.1%) | 11/44 (25%) | |||
| Cardiac disorders | ||||||
| Angina pectoris | 1/47 (2.1%) | 2 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Bradycardia | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Cardiac flutter | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Mitral valve incompetence | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Palpitations | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Eye disorders | ||||||
| Eye pain | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 0/47 (0%) | 0 | 0/48 (0%) | 0 | 1/44 (2.3%) | 1 |
| Abdominal pain upper | 0/47 (0%) | 0 | 0/48 (0%) | 0 | 1/44 (2.3%) | 1 |
| Constipation | 2/47 (4.3%) | 2 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Diarrhoea | 0/47 (0%) | 0 | 2/48 (4.2%) | 2 | 1/44 (2.3%) | 1 |
| Faeces hard | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Gingival bleeding | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 1/44 (2.3%) | 1 |
| Nausea | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 1/44 (2.3%) | 1 |
| Toothache | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| General disorders | ||||||
| Chest discomfort | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Exercise tolerance decreased | 0/47 (0%) | 0 | 0/48 (0%) | 0 | 1/44 (2.3%) | 1 |
| Fatigue | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 1/44 (2.3%) | 1 |
| Feeling jittery | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Non-cardiac chest pain | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Oedema peripheral | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 1/44 (2.3%) | 1 |
| Vessel puncture site haematoma | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Vessel puncture site reaction | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Immune system disorders | ||||||
| Hypersensitivity | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Infections and infestations | ||||||
| Nasopharyngitis | 1/47 (2.1%) | 1 | 3/48 (6.3%) | 4 | 0/44 (0%) | 0 |
| Upper respiratory tract infection | 0/47 (0%) | 0 | 3/48 (6.3%) | 4 | 0/44 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Contusion | 4/47 (8.5%) | 6 | 3/48 (6.3%) | 4 | 1/44 (2.3%) | 1 |
| Head injury | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Joint injury | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Neck injury | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Investigations | ||||||
| Blood glucose increased | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1/47 (2.1%) | 1 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Back pain | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Muscle spasms | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Musculoskeletal pain | 0/47 (0%) | 0 | 1/48 (2.1%) | 2 | 0/44 (0%) | 0 |
| Musculoskeletal stiffness | 1/47 (2.1%) | 1 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Myalgia | 0/47 (0%) | 0 | 2/48 (4.2%) | 3 | 0/44 (0%) | 0 |
| Pain in jaw | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Nervous system disorders | ||||||
| Burning sensation | 0/47 (0%) | 0 | 0/48 (0%) | 0 | 1/44 (2.3%) | 1 |
| Dizziness | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Dizziness postural | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Headache | 1/47 (2.1%) | 1 | 4/48 (8.3%) | 4 | 0/44 (0%) | 0 |
| Psychiatric disorders | ||||||
| Insomnia | 0/47 (0%) | 0 | 2/48 (4.2%) | 2 | 0/44 (0%) | 0 |
| Nervousness | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Nicotine dependence | 0/47 (0%) | 0 | 1/48 (2.1%) | 2 | 1/44 (2.3%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Chronic obstructive pulmonary disease | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Cough | 0/47 (0%) | 0 | 1/48 (2.1%) | 2 | 1/44 (2.3%) | 1 |
| Dyspnoea | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 3/44 (6.8%) | 3 |
| Dyspnoea exertional | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Epistaxis | 1/47 (2.1%) | 1 | 1/48 (2.1%) | 1 | 1/44 (2.3%) | 1 |
| Hyperventilation | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Sleep apnoea syndrome | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 0/44 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Dyshidrosis | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Ecchymosis | 0/47 (0%) | 0 | 0/48 (0%) | 0 | 2/44 (4.5%) | 4 |
| Hyperhidrosis | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Increased tendency to bruise | 0/47 (0%) | 0 | 0/48 (0%) | 0 | 1/44 (2.3%) | 1 |
| Rash | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Vascular disorders | ||||||
| Flushing | 0/47 (0%) | 0 | 0/48 (0%) | 0 | 1/44 (2.3%) | 2 |
| Haemorrhage | 0/47 (0%) | 0 | 1/48 (2.1%) | 1 | 1/44 (2.3%) | 1 |
| Hot flush | 1/47 (2.1%) | 1 | 0/48 (0%) | 0 | 0/44 (0%) | 0 |
| Hypertension | 0/47 (0%) | 0 | 2/48 (4.2%) | 2 | 0/44 (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:
,
,
ClinicalTrials.gov Identifier:
NCT00356135
Other Study ID Numbers:
- 10631
- H7T-MC-TABM
First Posted:
Jul 25, 2006
Last Update Posted:
Nov 3, 2010
Last Verified:
Oct 1, 2010