drugset / Trial / NCT01107925

Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight With Coronary Artery Disease

NCT01107925 ↗

Phase 1 Completed 72 enrolled Eli Lilly and Company Daiichi Sankyo · collab
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2010-03
Primary completion
2011-08
Completion
2011-08

Outcome

Met primary endpoint

paper Reduction in platelet reactivity with prasugrel 5 mg in low-body-weight patients is noninferior to prasugrel 10 mg in higher-body-weight patients PMID 23083774 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clopidogrel Small molecule 75 mg Oral
Subject Prasugrel Small molecule 5 mg Oral
Subject Prasugrel Small molecule 10 mg Oral