At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 72 enrolled
Drug / intervention
prasugrel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating prasugrel and clopidogrel for Coronary Artery Disease. Completed, enrolled 72 participants across 6 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesIreland, Netherlands, Sweden, United States
CollaboratorsDaiichi Sankyo Co., Ltd.
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedApr 2010
Primary CompletionAug 2011
TodayJul 2026
First PostedApr 21, 2010
Enrollment StartMar 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.2 years ago
Interventions
prasugreldrug
Administered orally, daily for 12 days
clopidogreldrug
Administered orally, daily for 12 days