EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)

Last updated: February 8, 2010
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Arrhythmia

Atrial Fibrillation

Chest Pain

Treatment

N/A

Clinical Study ID

NCT00259428
EFC3153
SR33589B
  • Ages > 21
  • All Genders

Study Summary

To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).

To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.

To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour atthe time of randomization and with at least one ECG-documented AF/AFL episode in thelast 3 months.

Exclusion

Exclusion Criteria:

  • MAIN CRITERIA (non-exhaustive list, see protocol for details): Women of childbearing potential without adequate birth control, Pregnant women,Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions whichincrease the risk of severe antiarrhythmic drug side effects, Severe associated conditions.

Study Design

Total Participants: 615
Study Start date:
November 01, 2001
Estimated Completion Date:
August 31, 2003

Study Description

This is a double-blind, parallel arm, placebo-controlled, multicentre, multinational, phase III study.

To be eligible, patients must be in normal sinus rhythm at randomisation and must have an ECG-documented history of recent AF/AFL reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion

Connect with a study center

  • Sanofi-Aventis Administrative Office

    Diegem,
    Belgium

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Praha,
    Czech Republic

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Horsholm,
    Denmark

    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

    Budapest,
    Hungary

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Milano,
    Italy

    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

    Barcelona,
    Spain

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Guildford,
    United Kingdom

    Site Not Available

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