Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF).

Trial Profile

Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF).

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Jun 2011

At a glance

  • Drugs Amiodarone; Dronedarone
  • Indications Atrial fibrillation
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms DIONYSOS
  • Sponsors Sanofi
  • Most Recent Events

    • 02 Jul 2009 The US FDA approves dronedarone [Multaq] for Patients With atrial fibrillation or atrial Flutter, according to sanofi-aventis media release.
    • 24 Mar 2009 Actual number of patients changed from 504 to 505 as reported by ClinicalTrials.gov.
    • 23 Dec 2008 Primary endpoint 'Disease recurrence' has been met.
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