NCT01015729

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

An Open-Label, Randomized, Single-Center, 3-Way Crossover Study Comparing The Therapeutic Efficacy of a Fixed Dose Combination Capsule of Esomeprazole 20 mg And Acetylsalicylic Acid (ASA) 81 mg With Free Combinations of ASA Tablet 81 mg And Esomeprazole 20 mg as a Capsule or Tablet in Patients At Risk of Gastrointestinal Events Using Low Dose ASA for Cardiovascular Protection

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peptic Ulcer Disease

Interventions

Type	Name	Description
DRUG	Esomeprazole/ASA Fixed Combination	Capsule, oral, single dose
DRUG	Esomeprazole	oral, single dose
DRUG	ASA	Tablet, oral, single dose

Timeline

• Start date: 2009-11-01
• Completion: 2010-03-01
• First posted: 2009-11-18
• Last updated: 2012-01-16

Locations

1 site across 1 country: Canada