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

Phase 3

Completed

• Conditions: Non-valvular Atrial Fibrillation
• Interventions: Drug: DU-176b 30mg; Drug: DU-176b 60mg; Drug: DU-176b 15mg

• Registration Number: NCT01857622
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

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

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-20
• Status Verified: 2015-01
• Results First Submitted: 2015-01-15
• Results First Submitted QC: 2015-01-15
• Results First Posted: 2015-01-26
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal/MiRI low-dose group	DU-176b 30mg	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.
Normal/MiRI high-dose group	DU-176b 60mg	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.
SRI 15mg	DU-176b 15mg	DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Incidence of Any Adjudicated Bleeding Events	3 months	Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)

Trial Locations

Locations (1)

Tokyo Women's Medical University Hospital; 🇯🇵 Tokyo, Japan