Clinical trial
Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus…
NCT00489736 · Sanofi, Industry · Completed
Key facts
| NCT number | NCT00489736 |
|---|---|
| Title | Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation |
| Official title | 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) |
| Acronym | DIONYSOS |
| Lead sponsor | Sanofi, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Atrial Fibrillation |
| Intervention type | Drug |
| Interventions | dronedarone (SR33589), amiodarone |
| Enrollment | 504 |
| Start date | Jun 1, 2007 |
| Primary completion | Oct 1, 2008 |
| Completion | Oct 1, 2008 |
| First posted | Jun 21, 2007 |
| Last update posted | Feb 18, 2010 |
| Countries | Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czechia, Estonia, Finland, France, Germany and 11 more |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: