NCT01857622

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	DU-176b 15mg	oral DU-176b 15mg once daily
DRUG	DU-176b 30mg	oral DU-176b 30mg once daily
DRUG	DU-176b 60mg	oral DU-176b 60mg once daily

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2013-05-20
• Last updated: 2019-03-05
• Results posted: 2015-01-26

Locations

1 site across 1 country: Japan