Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

Summary

This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, \& Warfarin. The expected duration of the study is 24 months.

Conditions

• Stroke
• Atrial Fibrillation
• Embolism

Interventions

DRUG

warfarin tablets

Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months

DRUG

Edoxaban tablets (high dose regimen-60mg)

Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

DRUG

Edoxaban tablets (low dose regimen-30mg)

Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

DRUG

placebo warfarin

placebo warfarin

DRUG

placebo edoxaban

placebo edoxaban

Sponsors & Collaborators

• The TIMI Study Group

  collaborator OTHER

• Daiichi Sankyo

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2013-04-30

Completion

2013-05-31

Countries

• United States
• Argentina
• Australia
• Belgium
• Brazil
• Bulgaria
• Canada
• Chile
• China
• Colombia
• Croatia
• Czechia
• Denmark
• Estonia
• Finland
• France
• Germany
• Greece
• Guatemala
• Hungary
• India
• Israel
• Italy
• Japan
• Mexico
• Netherlands
• New Zealand
• Norway
• Peru
• Philippines
• Poland
• Portugal
• Romania
• Russia
• Serbia
• Slovakia
• South Africa
• South Korea
• Spain
• Sweden
• Switzerland
• Taiwan
• Thailand
• Turkey (Türkiye)
• Ukraine
• United Kingdom

Study Locations