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NCT00174785 · ClinicalTrials.gov registry record · Phase 3
A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation
A Phase 3 study of Atrial Fibrillation and Atrial Flutter, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,628
- Enrollment target
- 20
- Study locations
NCT00174785 is a Phase 3 study of Atrial Fibrillation and Atrial Flutter that has completed, run by Sanofi. The registered enrollment target is 4,628 participants, above the 2,974-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 2 states.
The verdict
NCT00174785, a Phase 3 study of Atrial Fibrillation and Atrial Flutter, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,628 participants
- Enrollment target
- 20
- Study locations
Study Summary
To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL). To assess that dronedarone is well tolerated in this population.
Conditions Studied
Interventions
- DRUG placebo
- DRUG dronedarone (SR33589)
Study Locations (20)
Other
- Sanofi-Aventis Administrative Office - Buenos Aires
- Sanofi-Aventis Administrative Office - New South Wales
- 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 - Helsinki
- Sanofi-aventis Administrative Office - Berlin
- Sanofi-Aventis Administrative Office - Athens
- Sanofi-Aventis Administrative Office - Causeway Bay
- Sanofi-Aventis Administrative Office - Budapest
- Sanofi-Aventis Administrative Office - Mumbai
- Sanofi-Aventis Administrative Office - Netanya
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - Kuala Lumpur
- Sanofi-Aventis Administrative Office - México
- Sanofi-Aventis Administrative Office - Casablanca
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,628 participants |
| Start Date | 2005-06 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00174785
The ClinicalTrials.gov registry entry for NCT00174785 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,628 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,974-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (56% higher). 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.
NCT00174785 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00174785 about?
NCT00174785 is a clinical study titled "A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation". To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL). To assess that dronedarone is well tolerated in this population.
What is the current status of trial NCT00174785?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,628 participants. The study started on 2005-06. Estimated completion is 2008-03.
What conditions does trial NCT00174785 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Atrial Flutter.
What interventions are being tested in trial NCT00174785?
The interventions under investigation include: placebo (DRUG), dronedarone (SR33589) (DRUG).
Who is sponsoring clinical trial NCT00174785?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00174785 being conducted?
This trial has 20 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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