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NCT00249795 · ClinicalTrials.gov registry record · Phase 3
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)
A Phase 3 study of Atrial Fibrillation and Cardiovascular Disease, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 9,016
- Enrollment target
- 20
- Study locations
NCT00249795: Completed Phase 3 study of Atrial Fibrillation and Cardiovascular Disease, sponsored by Sanofi.
NCT00249795 is a Phase 3 study of Atrial Fibrillation and Cardiovascular Disease that has completed, run by Sanofi. The registered enrollment target is 9,016 participants, above the 2,952-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (205% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00249795, a Phase 3 study of Atrial Fibrillation and Cardiovascular Disease, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 9,016 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.
Primary Outcome
The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).
Conditions Studied
Interventions
- DRUG placebo
- DRUG Irbesartan
Study Locations (20)
Other
- Sanofi-Aventis Administrative Office - Buenos Aires
- Sanofi-Aventis Administrative Office - Macquarie Park
- Sanofi-Aventis Administrative Office - Vienna
- Sanofi-Aventis Administrative Office - Diegem
- Sanofi-Aventis Administrative Office - São Paulo
- Sanofi-Aventis Administrative Office - Laval
- Sanofi-Aventis Administrative Office - Santiago
- Sanofi-Aventis Administrative Office - Prague
- Sanofi-Aventis Administrative Office - Hørsholm
- Sanofi-Aventis Administrative Office - Helsinki
- Sanofi-Aventis Administrative Office - Paris
- 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 - Milan
- Sanofi-Aventis Administrative Office - Kuala Lumpur
- Sanofi-Aventis Administrative Office - México
- Sanofi-Aventis Administrative Office - Gouda
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9,016 participants |
| Start Date | 2003-06 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00249795 record still lists
NCT00249795 is an interventional study that assigns participants to a tested intervention. Its 9,016 participants enrollment target places it among the larger protocols in the corpus, above the 2,952-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (205% 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.
NCT00249795 names 20 study sites across 2 states, led by Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00249795 about?
NCT00249795 is a clinical study titled "Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)". The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.
What is the current status of trial NCT00249795?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 9,016 participants. The study started on 2003-06. Estimated completion is 2009-08.
What conditions does trial NCT00249795 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Cardiovascular Disease.
What interventions are being tested in trial NCT00249795?
The interventions under investigation include: placebo (DRUG), Irbesartan (DRUG).
Who is sponsoring clinical trial NCT00249795?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00249795 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
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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 NCT00249795's enrollment target sits among peer trials
9,016 14th of 202 higher than 189 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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