A phase 2, double-blind, double-dummy, randomised, parallel group dose finding study to investigate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation and to compare the safety and tolerability with warfarin.

Trial Profile

A phase 2, double-blind, double-dummy, randomised, parallel group dose finding study to investigate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation and to compare the safety and tolerability with warfarin.

Completed
Phase of Trial: Phase II

Latest Information Update: 20 Apr 2017

At a glance

  • Drugs Darexaban (Primary) ; Warfarin
  • Indications Stroke; Thromboembolism
  • Focus Adverse reactions
  • Acronyms OPAL2
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 02 Apr 2012 EudraCT reports actual initiation date as 28 May 2009.
    • 16 Nov 2011 Planned number of patients changed from 1280 to 1320 as reported by European Clinical Trials Database.
    • 28 Jul 2011 Results of an analysis of the effects of treatment on thrombogenesis markers presented at the 23rd Congress of the International Society on Thrombosis and Haemostasis.
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