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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 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.

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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.

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

FieldValue
Enrollment Target 9,016 participants
Start Date 2003-06
Est. Completion 2009-08
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00249795

The ClinicalTrials.gov registry entry for NCT00249795 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 9,016 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,952-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (205% 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.

NCT00249795 reports 20 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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