drugset / Trial / NCT01015729

Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately

NCT01015729

Phase 1 Terminated 30 enrolled AstraZeneca
RandomizedCrossoverOpen-label

Summary

The purpose of this study is to investigate whether a fixed dose combination (FDC) capsule of esomeprazole 20 mg and acetylsalicylic acid (ASA) 81 mg has equivalent therapeutic efficacy compared to each of 2 free combinations of ASA tablet 81 mg plus esomeprazole 20 mg in patients at risk of gastrointestinal events using low dose ASA for cardiovascular protection.

Timeline

Start
2009-11
Primary completion
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetylsalicylic Acid Unknown 81 mg Oral
Comparator Acetylsalicylic Acid Unknown 325 mg Oral
Comparator Esomeprazole Small molecule 20 mg Oral

Indications