Phase III Clinical Study of DU-176b (non-valvular atrial fibrillation): Japanese, Multicenter, Open-label Study of DU-176b in Patients with non-valvular atrial fibrillation and Severe Renal Impairment
Phase 2
- Conditions
- on-valvular atrial fibrillation
- Registration Number
- JPRN-jRCT2080221674
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Patients with non-valvular atrial fibrillation and severe renal impairment, or normal renal function or mild renal impairment
Exclusion Criteria
-Patients on hemodialysis or patients who may start hemodialysis before the follow-up assessment
-Patients at risk for bleeding
-Patients who are receiving treatment with any anticoagulant drugs excluding warfarin and dabigatran
-Patients with evidence of hepatic dysfunction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety endpoints[Incidence of all bleeding events, adverse events and adverse drug reactions]
- Secondary Outcome Measures
Name Time Method