JRCT ID: jRCT2080221059
Registered date:05/04/2010
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | 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 |
Date of first enrollment | 05/04/2010 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | 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 |
Outcome(s)
Primary Outcome | Frequency of gastric or duodenal ulcer |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | AstraZeneca |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-101092 |
Contact
Public contact | |
Name | |
Address | RD-clinical-information-Japan@astrazeneca.com |
Telephone | |
Affiliation | AstraZeneca KK |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |