A Placebo-Controlled,Double-Blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in patiENts With Atrial Fibrillation/Atrial Flutter (AF/AFL)

Trial Profile

A Placebo-Controlled,Double-Blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in patiENts With Atrial Fibrillation/Atrial Flutter (AF/AFL)

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Sep 2011

At a glance

  • Drugs Dronedarone (Primary)
  • Indications Atrial fibrillation; Atrial flutter; Cardiovascular disorders; Death
  • Focus Registrational; Therapeutic Use
  • Acronyms ATHENA
  • Sponsors Sanofi
  • Most Recent Events

    • 31 Aug 2011 Results from a subgroup analysis in patients with permanent atrial fibrillation were presented at the ESC Congress 2011: Annual Congress of the European Society of Cardiology.
    • 25 Sep 2009 The Committee for Medicinal Products for Human Use has adopted a positive opinion of dronedarone based on the results of seven trials, including ATHENA, according to a Sanofi-aventis media release.
    • 02 Jul 2009 The US FDA approves dronedarone [Multaq] for Patients With atrial fibrillation or atrial Flutter, according to sanofi-aventis media release.
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