NCT00806624

DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation

A Phase 2, Randomized, Parallel Group, Multi-Center, Multi-National Study for the Evaluation of Safety and Efficacy of Two Fixed Dosages of DU-176b in Subjects With Non-Valvular Atrial Fibrillation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses. Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary endpoints are incidence of major, clinically relevant non-major and minor bleeding events (all bleeding).

Conditions

• Atrial Fibrillation
• Stroke

Interventions

Type	Name	Description
DRUG	DU-176b tablets	DU-176b tablets taken once daily for up to 3 months
DRUG	DU-176b tablets	DU-176b tablets taken once daily for up to 3 months
DRUG	Warfarin tablets	Warfarin tablets taken once daily for up to 3 months

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-10-01
• Completion: 2009-11-01
• First posted: 2008-12-11
• Last updated: 2019-02-26
• Results posted: 2015-01-26

Locations

4 sites across 4 countries: China, Singapore, South Korea, Taiwan