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

Non-valvular Atrial Fibrillation Clinical Trial

Official title:

Phase III Clinical Study of DU-176b (Non-valvular Atrial Fibrillation): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Non-valvular Atrial Fibrillation and Severe Renal Impairment (SRI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857622
• Other study ID #: DU176b-B-J307
• Status: Completed
• Phase: Phase 3
• Start date: November 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2015
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation
• Renal Insufficiency

Intervention

Drug:
• DU-176b 15mg
oral DU-176b 15mg once daily
• DU-176b 30mg
oral DU-176b 30mg once daily
• DU-176b 60mg
oral DU-176b 60mg once daily

Locations

Country	Name	City	State
Japan	Tokyo Women's Medical University Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Any Adjudicated Bleeding Events	Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)	3 months