NCT00504556

A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,146 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.

Conditions

• Atrial Fibrillation
• Thromboembolism

Interventions

Type	Name	Description
DRUG	Edoxaban (DU-176b)	30mg tablet once daily
DRUG	Edoxaban (DU-176b)	60mg tablet once daily
DRUG	Edoxaban (DU-176b)	30mg tablet two times a day
DRUG	Edoxaban (DU-176b)	60mg tablet two times a day
DRUG	warfarin	warfarin tablets

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-07-20
• Last updated: 2019-02-26
• Results posted: 2015-03-13

Locations

91 sites across 12 countries: United States, Belarus, Belgium, Bosnia and Herzegovina, Canada, Chile, Latvia, Mexico, Moldova, Russia, Slovakia, Ukraine