Status:
COMPLETED
Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Non-valvular Atrial Fibrillation
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial f...
Eligibility Criteria
Inclusion
- Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI.
Exclusion
- Patients who are on hemodialysis or patients who may start hemodialysis before the follow-up assessment
- Patients who are at a significantly high risk for bleeding
- Patients who are receiving treatment with any anticoagulant drugs excluding warfarin, rivaroxaban, and dabigatran
- Patients who have evidence of hepatic function test abnormalities
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01857622
Start Date
November 1 2011
End Date
January 1 2013
Last Update
March 5 2019
Active Locations (1)
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1
Tokyo Women's Medical University Hospital
Tokyo, Japan, 162-0054