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 Results

Summary 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...

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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

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