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drugset / Trial / NCT01857622

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

NCT01857622 ↗

Phase 3 Completed 93 enrolled Daiichi Sankyo
RandomizedParallel-groupOpen-labelPrevention

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).

Timeline

Start
2011-11
Primary completion
2013-01
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Edoxaban Small molecule 15 mg Oral
Subject Edoxaban Small molecule 30 mg Oral
Subject Edoxaban Small molecule 60 mg Oral

Indications

atrial fibrillation