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NCT00489736 · ClinicalTrials.gov registry record · Phase 3

Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

A Phase 3 study of Atrial Fibrillation, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
504
Enrollment target
20
Study locations

NCT00489736 is a Phase 3 study of Atrial Fibrillation that has completed, run by Sanofi. The registered enrollment target is 504 participants, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 2 states.

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The verdict

NCT00489736, a Phase 3 study of Atrial Fibrillation, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
504 participants
Enrollment target
20
Study locations

Study Summary

The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

Conditions Studied

Interventions

  • DRUG dronedarone (SR33589)
  • DRUG amiodarone

Study Locations (20)

Other

  • Sanofi-Aventis Administrative Office - Buenos Aires
  • Sanofi-Aventis Administrative Office - Cove
  • 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 - Tallinn
  • Sanofi-Aventis Administrative Office - Helsinki
  • Sanofi-Aventis Administrative Office - Paris
  • Sanofi-Aventis Administrative Office - Berlin
  • Sanofi-Aventis Administrative Office - Milan
  • Sanofi-Aventis Administrative Office - México
  • Sanofi-Aventis Administrative Office - Casablanca
  • Sanofi-Aventis Administrative Office - Gouda
  • Sanofi-Aventis Administrative Office - Warsaw
  • Sanofi-Aventis Administrative Office - Moscow
  • Sanofi-Aventis Administrative Office - Seoul

New Jersey

  • Sanofi-Aventis Administrative Office - Bridgewater

Trial Details

FieldValue
Enrollment Target 504 participants
Start Date 2007-06
Est. Completion 2008-10
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00489736

The ClinicalTrials.gov registry entry for NCT00489736 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 504 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 (83% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which dronedarone (SR33589) is the first listed.

NCT00489736 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.

Frequently Asked Questions

What is clinical trial NCT00489736 about?

NCT00489736 is a clinical study titled "Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation". The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

What is the current status of trial NCT00489736?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 504 participants. The study started on 2007-06. Estimated completion is 2008-10.

What conditions does trial NCT00489736 study?

This clinical trial studies the following conditions: Atrial Fibrillation.

What interventions are being tested in trial NCT00489736?

The interventions under investigation include: dronedarone (SR33589) (DRUG), amiodarone (DRUG).

Who is sponsoring clinical trial NCT00489736?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00489736 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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