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

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2010
INTERVENTION: 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 : Oral(capsule) 20mg, once daily for 72 weeks control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : Oral(capsule) Placebo, once daily for 72 weeks CONDITION: 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 PRIMARY OUTCOME: Frequency of gastric or duodenal ulcer 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
Epistemonikos ID: ec1e86444139ca2ace1954f45307d06f5ae92929
First added on: Aug 26, 2024