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: 18 May 2018

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

    • 18 May 2018 Sub-analysis results presented in the Daiichi Sankyo Company media release.
    • 18 May 2018 According to the Daiichi Sankyo Company media release, new sub-analysis data from this study were presented at the 4th European Stroke Organisation Congress 2018.
    • 03 May 2018 Results (n=7,193) assessing compared outcomes in patients on warfarin or edoxaban enrolled in ENGAGE AF-TIMI 48 who underwent a surgery or invasive procedure, were published in the Thrombosis and Haemostasis.
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