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: 15 Nov 2017

At a glance

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

    • 15 Nov 2017 Results comparing the events across definitions of major bleeding within a single at-risk patient cohort, presented at the 90th Annual Scientific Sessions of the American Heart Association.
    • 15 Nov 2017 Results presented at the 90th Annual Scientific Sessions of the American Heart Association
    • 15 Nov 2017 Results of sub-analysis were presented in a Daiichi Sankyo Company media release.
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