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

Last updated: February 15, 2010
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Arrhythmia

Chest Pain

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT00489736
EFC4968
  • Ages > 21
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with documented atrial fibrillation for more than 72 hours for whomcardioversion and antiarrhythmic treatment is indicated in the opinion of theinvestigator and under oral anticoagulation

Exclusion

Exclusion Criteria:

  • Contraindication to oral anticoagulation

  • Patient having received amiodarone in the past whatever the date (more than a total oftwenty 200 mg tablets or more than 5 days intravenous)

  • Patients known to have chronic AF, patients with atrial flutter or paroxysmal atrialfibrillation

  • Severe congestive heart failure with New-York Heart Association (NYHA) class III orIV, severe bradycardia, high degree atrio-ventricular block, ongoing potentiallydangerous symptoms when in AF such as angina pectoris, transient ischemic attacks,stroke, syncope, as judged by the investigator, first degree family history of suddencardiac death below age 50 years in the absence of coronary heart disease, significantsinus node disease without a permanent pacemaker implanted

  • History of torsades de pointes or long QT syndrome or QT- or QTc-interval ≥500 msecsbefore randomization

  • Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued

  • Dysthyroidism or other contraindication to amiodarone The above information are not intended to contain all the considerations relevant to apatient's potential participation in a clinical trial.

Study Design

Total Participants: 504
Study Start date:
June 01, 2007
Estimated Completion Date:
October 31, 2008

Connect with a study center

  • Sanofi-Aventis Administrative Office

    Buenos Aires,
    Argentina

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Cove,
    Australia

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Vienna,
    Austria

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Diegem,
    Belgium

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Laval,
    Canada

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Santiago,
    Chile

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Shangaï,
    China

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Shangaï,
    China

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Praha,
    Czech Republic

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Tallinn,
    Estonia

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Helsinki,
    Finland

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Paris,
    France

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Berlin,
    Germany

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Milan,
    Italy

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Seoul,
    Korea, Republic of

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Mexico,
    Mexico

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Casablanca,
    Morocco

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Gouda,
    Netherlands

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Warszawa,
    Poland

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Moscow,
    Russian Federation

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Bromma,
    Sweden

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Megrine,
    Tunisia

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Istanbul,
    Turkey

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Bridgewater, New Jersey 08807
    United States

    Site Not Available

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