Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation "EngageAFTIMI48"
Completed
Phase 3 ResultsSummary of Purpose
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...
Read More →Trial Milestones
The following dates are available for this trial. Trial information last updated on 12 March 2015.
1 Nov 2008 | 28 Oct 2008 | 1 Apr 2013 | 1 May 2013 | 1 Mar 2015 | 5 Feb 2015 |
Start Date | First Received | 1st Completion | Completion | Verification | Results |
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Trial Design
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Contacts
-
Shirali Patel 919-998-1452
shirali.patel@quintiles.com
View Trial Locations
Recruitment
- Enrollment: 21,105
- Gender: Both
- Minimum Age: 21 Years
- Accepts Healthy Volunteers: No
- 1018 locations, 46 countries