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NCT00489736 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
A Phase 3 study of Atrial Fibrillation, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 504
- Enrollment target
- 20
- Study locations
NCT00489736: Completed Phase 3 study of Atrial Fibrillation, sponsored by Sanofi.
NCT00489736 is a Phase 3 study of Atrial Fibrillation that has completed, run by Sanofi. The registered enrollment target is 504 participants, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00489736, a Phase 3 study of Atrial Fibrillation, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 504 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The "Measured Values" table below presents the numbers of patients with the event at the end of the study period.
Conditions Studied
Interventions
- DRUG dronedarone (SR33589)
- DRUG amiodarone
Study Locations (20)
Other
- Sanofi-Aventis Administrative Office - Buenos Aires
- Sanofi-Aventis Administrative Office - Cove
- Sanofi-Aventis Administrative Office - Vienna
- Sanofi-Aventis Administrative Office - Diegem
- Sanofi-Aventis Administrative Office - Laval
- Sanofi-Aventis Administrative Office - Santiago
- Sanofi-Aventis Administrative Office - Shangaï
- Sanofi-Aventis Administrative Office - Prague
- Sanofi-Aventis Administrative Office - Tallinn
- Sanofi-Aventis Administrative Office - Helsinki
- Sanofi-Aventis Administrative Office - Paris
- Sanofi-Aventis Administrative Office - Berlin
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - México
- Sanofi-Aventis Administrative Office - Casablanca
- Sanofi-Aventis Administrative Office - Gouda
- Sanofi-Aventis Administrative Office - Warsaw
- Sanofi-Aventis Administrative Office - Moscow
- Sanofi-Aventis Administrative Office - Seoul
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00489736 record still lists
NCT00489736 is an interventional study that assigns participants to a tested intervention. The registered 504 participants enrollment target is mid-sized for trials with a published cap, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which dronedarone (SR33589) is the first listed.
NCT00489736 names 20 study sites across 2 states, led by Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00489736 about?
NCT00489736 is a clinical study titled "Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation". 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.
What is the current status of trial NCT00489736?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 504 participants. The study started on 2007-06. Estimated completion is 2008-10.
What conditions does trial NCT00489736 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT00489736?
The interventions under investigation include: dronedarone (SR33589) (DRUG), amiodarone (DRUG).
Who is sponsoring clinical trial NCT00489736?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00489736 being conducted?
This trial has 20 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atrial Fibrillation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00489736's enrollment target sits among peer trials
504 59th of 202 higher than 144 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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