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: 30 Aug 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

    • 30 Aug 2017 Results of a subanalysis assessing the differential efficacy and safety of edoxaban versus well managed warfarin in relation to CHA2DS2VASc score, presented at the ESC Congress 2017: Annual Congress of the European Society of Cardiology.
    • 30 Aug 2017 Results of comaprison of treatment in patients with mild hepatic disease versus without mild hapetic disease presented at the ESC Congress 2017: Annual Congress of the European Society of Cardiology
    • 29 Aug 2017 According to a Daiichi Sankyo Company media release, results of subgroup analysis have been presented at the European Society of Cardiology 2017.
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