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

NCT ID: NCT01857622

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-01-31

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).

Conditions

Non-valvular Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SRI 15mg

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

Group Type: EXPERIMENTAL

DU-176b 15mg

Intervention Type: DRUG

oral DU-176b 15mg once daily

Normal/MiRI low-dose group

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.

Group Type: EXPERIMENTAL

DU-176b 30mg

Intervention Type: DRUG

oral DU-176b 30mg once daily

Normal/MiRI high-dose group

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.

Group Type: EXPERIMENTAL

DU-176b 60mg

Intervention Type: DRUG

oral DU-176b 60mg once daily

Interventions

DU-176b 15mg

oral DU-176b 15mg once daily

Intervention Type: DRUG

DU-176b 30mg

oral DU-176b 30mg once daily

Intervention Type: DRUG

DU-176b 60mg

oral DU-176b 60mg once daily

Intervention Type: DRUG

Other Intervention Names

edoxaban; edoxaban; edoxaban

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yukihiro Koretsune, Dir

Role: PRINCIPAL_INVESTIGATOR

Osaka National Hospital

Locations

Tokyo Women's Medical University Hospital

Tokyo, , Japan

Countries

Japan

Other Identifiers

DU176b-B-J307

Identifier Type: -

Identifier Source: org_study_id