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NCT00259376 · ClinicalTrials.gov registry record · Phase 3
American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm
A Phase 3 study of Atrial Fibrillation and Atrial Flutter, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 629
- Enrollment target
- 5
- Study locations
NCT00259376 is a Phase 3 study of Atrial Fibrillation and Atrial Flutter that has completed, run by Sanofi. The registered enrollment target is 629 participants, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (79% lower). The trial reports 5 study locations across 2 states.
The verdict
NCT00259376, a Phase 3 study of Atrial Fibrillation and Atrial Flutter, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 629 participants
- Enrollment target
- 5
- Study locations
Study Summary
To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL). To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence. To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.
Conditions Studied
Interventions
- DRUG placebo
- DRUG Dronedarone (SR33589)
Study Locations (5)
Other
- Sanofi-Aventis Administrative Office - Buenos Aires
- sanofi-aventis Australia administrative office - Macquarie Park
- Sanofi-Aventis Administrative Office - Laval
- Sanofi-Aventis Administrative Office - Midrand
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 629 participants |
| Start Date | 2001-11 |
| Est. Completion | 2003-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00259376
The ClinicalTrials.gov registry entry for NCT00259376 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 629 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (79% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00259376 reports 5 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00259376 about?
NCT00259376 is a clinical study titled "American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm". To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL). To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/...
What is the current status of trial NCT00259376?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 629 participants. The study started on 2001-11. Estimated completion is 2003-09.
What conditions does trial NCT00259376 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Atrial Flutter.
What interventions are being tested in trial NCT00259376?
The interventions under investigation include: placebo (DRUG), Dronedarone (SR33589) (DRUG).
Who is sponsoring clinical trial NCT00259376?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00259376 being conducted?
This trial has 5 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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