drugset / Trial / NCT01557335

A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540

NCT01557335 ↗

Phase 1 Completed 30 enrolled POZEN
RandomizedCrossoverOpen-labelTreatment

Summary

This study is designed to provide data on platelet aggregation of PA32540 plus clopidogrel dosed separately compared to EC aspirin 81 mg plus EC omeprazole 40 mg plus clopidogrel dosed concomitantly.

Timeline

Start
2010-11
Primary completion
2011-02
Completion
2011-02

Outcome

Met primary endpoint

paper Inhibition of platelet aggregation was greater with spaced PA32540 + clopidogrel therapy vs synchronous clopidogrel + EC aspirin + EC omeprazole therapy (P = .004). PMID 23351820 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 81 mg —
Subject Clopidogrel Small molecule 75 mg —
Comparator Omeprazole Other / unclassified 40 mg —
Subject PA32540 Unknown — —