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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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221059
Enrollment
Unknown
Registered
2010-04-05
Start date
2010-04-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

investigational material(s) Generic name etc : D961H INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material :

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Frequency of gastric or duodenal ulcer

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026