A Phase 3 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
Phase 3
- Conditions
- Patient diagnosed as a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) that is taking the prescribed LDA continuously
- Registration Number
- JPRN-jRCT2080221059
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Provision of written informed consent before starting the study-related procedures and examinations
2. Patients who have the history of gastric and/or duodenal ulcer
3. A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period
Exclusion Criteria
1. Having gastric or duodenal ulcer (except for ulcer scar)
2. History of esophageal, gastric or duodenal surgery, except for simple closure of perforation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of gastric or duodenal ulcer
- Secondary Outcome Measures
Name Time Method