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)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 22 Dec 2021
Price :
$35
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At a glance
- Drugs Amiodarone (Primary) ; Dronedarone (Primary)
- 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.