drugset / Trial / NCT00989300

Influence of Rabeprazole on the Magnitude of the Antiplatelet Action of Clopidogrel

NCT00989300

Phase 1 Completed 39 enrolled Janssen Cilag S.A.S.
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to assess, whether the administration of a proton pump inhibitor, Rabeprazole, has a negative effect on the activity of a concomitantly administered blood thinner drug. Proton pump inhibitors (PPI's) are prescribed for patients with gastric problems to reduce the gastric acid secretion. The blood thinner drug, Clopidogrel, administered in this trial is approved for the treatment of mild heart attacks; it works by preventing blood platelets from sticking together to form clots that would restrict blood flow. Previous trials have shown that the proton pump inhibitor omeprazole interacts with the blood thinning drug clopidogrel to reduce the active form of clopidogrel, thereby preventing the drug's blood thinning effect. In this trial, the effect of two different proton pump inhibitors, namely rabeprazole and omeprazole on the activity of the blood thinner drug clopidogrel will be assessed and compared to the effect of placebo on the activity of the blood thinner drug clopidogrel. This will be done in three sequential periods and each of the patients enrolled into this trial will be asked to participate in three different periods, during which clopidogrel with either rabeprazol, or omeprazol, or placebo will be administered daily.

Timeline

Start
2009-11
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Clopidogrel Small molecule 75 mg Oral
Subject Omeprazole Other / unclassified 20 mg Oral
Subject Rabeprazole Small molecule 20 mg Oral

Indications

No indication recorded.