Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose aspirin

Study identifier:D961PC00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg once daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated with Continuous Low-dose Aspirin (LDA) Use

Medical condition

Prevention

Phase

Phase 3

Healthy volunteers

No

Study drug

Esomeprazole, Placebo

Sex

All

Actual Enrollment

427

Study type

Interventional

Age

20 Years +

Date

Study Start Date: 01 Feb 2010
Primary Completion Date: 01 Nov 2011
Study Completion Date: 01 Nov 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Oct 2012 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria