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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Non-valvular Atrial Fibrillation

Treatments: Drug: DU-176b 60mg; Drug: DU-176b 30mg; Drug: DU-176b 15mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01857622

DU176b-B-J307

Details and patient eligibility

About

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).

Enrollment: 93 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

SRI 15mg

Experimental group

Description:

DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.

Treatment:

Drug: DU-176b 15mg

Normal/MiRI low-dose group

Experimental group

Description:

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.

Treatment:

Drug: DU-176b 30mg

Normal/MiRI high-dose group

Experimental group

Description:

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.

Treatment:

Drug: DU-176b 60mg