A Phase 3, randomized, double-blind, double-dummy, parallel group, multi-center, multi-national study for evaluation of efficacy and safety of DU-176b versus warfarin in subjects with atrial fibrillatio
Phase 3
- Conditions
- Patients with atrial fibrillation
- Registration Number
- JPRN-jRCT2080220747
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd., DAIICHI SANKYO PHARMA DEVELOPMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 20500
Inclusion Criteria
Documented AF on ECG
Exclusion Criteria
- Subjects with any contraindication for anticoagulant agents
- Subjects with conditions associated with high risk of bleeding
- Females of childbearing potential
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The composite primary endpoint of stroke and systemic embolic events.
- Secondary Outcome Measures
Name Time Method - The composite clinical outcome of stroke, SEE, and all-cause mortality.<br>- Major bleeding events