NCT00829933

Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial Fibrillation

A Randomized Dose-ranging Controlled Trial of DU-176b Versus Warfarin Potassium in Patients With Non-valvular Atrial Fibrillation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 536 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). The secondary objective includes between-group comparisons with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for the safety evaluation.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	DU-176b tablets	DU-176b tablets taken once daily for up to 12 weeks
DRUG	Warfarin potassium tablets	Warfarin potassium tablets taken once daily for up to 12 weeks

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-07-01
• Completion: 2008-09-01
• First posted: 2009-01-27
• Last updated: 2019-02-25
• Results posted: 2015-01-26

Locations

1 site across 1 country: Japan