A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48).

Trial Profile

A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48).

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2017

At a glance

  • Drugs Edoxaban (Primary) ; Warfarin
  • Indications Atrial fibrillation; Stroke; Thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ENGAGE-AF; ENGAGE-AF-TIMI-48
  • Sponsors Daiichi Sankyo Inc
  • Most Recent Events

    • 13 Mar 2017 According to a Daiichi Sankyo media release, four abstracts highlighting subgroup analyses from this study will be presented at the American College of Cardiology's (ACC) 66th Annual Scientific Session, March 2017.
    • 12 Mar 2017 Results assessing outcomes in patients with atrial fibrillation with and without valvular heart disease (n=21,046) , published in the Journal of the American College of Cardiology.
    • 06 Jan 2017 Results published in the European Heart Journal
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