Conditions: Non-valvular Atrial Fibrillation
Keywords: anticoagulant DU-176b edoxaban factor Xa oral atrial fibrillation severe renal impairment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 93
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks. arm 2: DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. arm 3: DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.

Interventions: intervention 1: DU-176b 15mg intervention 2: DU-176b 30mg intervention 3: DU-176b 60mg
Intervention descriptions: intervention 1: oral DU-176b 15mg once daily intervention 2: oral DU-176b 30mg once daily intervention 3: oral DU-176b 60mg once daily

Protocol document: