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).
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History