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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: Completed Phase 3 study of Atrial Fibrillation and Atrial Flutter, sponsored by Sanofi.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization 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 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 |
What the finished NCT00174785 record still lists
NCT00174785 is an interventional study that assigns participants to a tested intervention. Its 4,628 participants enrollment target places it among the larger protocols in the corpus, above the 2,974-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (56% higher).
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 names 20 study sites across 2 states, led by 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.
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 NCT00174785's enrollment target sits among peer trials
4,628 17th of 202 higher than 186 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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