At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 504 enrolled
Drug / intervention
dronedarone (SR33589) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating dronedarone (SR33589) and amiodarone for Atrial Fibrillation. Completed, enrolled 504 participants across 23 sites in 23 countries.
Detailed Summary
The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesArgentina, Australia, Austria, Belgium, Canada, Chile, China, Czechia, Estonia, Finland, France, Germany, Italy, Mexico, Morocco, Netherlands, Poland, Russia, South Korea, Sweden, Tunisia, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJun 2007
Primary CompletionOct 2008
TodayJul 2026
First PostedJun 21, 2007
Enrollment StartJun 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.0 years ago
Interventions
dronedarone (SR33589)drug
oral administration
amiodaronedrug
oral administration