Trials / Completed
CompletedNCT00781391
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 21,105 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2013-04-01
- Completion
- 2013-05-01
- First posted
- 2008-10-29
- Last updated
- 2019-03-05
- Results posted
- 2015-03-25
Locations
1,009 sites across 46 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
Source: ClinicalTrials.gov record NCT00781391. Inclusion in this directory is not an endorsement.