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

NCT01015729 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-01-16

No results posted yet for this study

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

DRUG

Esomeprazole/ASA Fixed Combination

Capsule, oral, single dose

DRUG

Esomeprazole

oral, single dose

DRUG

ASA

Tablet, oral, single dose

Sponsors & Collaborators

Principal Investigators

  • TJorgen Nasdal, MD, PhD · AstraZeneca R&D

  • Pierre Geoffroy, M.D. C.M., M.Sc., F.C.F.P. · Biovail Contract Research (BCR)

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Completion
2010-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015729 on ClinicalTrials.gov