Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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 fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Edoxaban

Criteria

Inclusion Criteria:

• Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI.

Exclusion Criteria:

• 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