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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259428
First Posted: November 29, 2005
Last Update Posted: February 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
November 25, 2005
November 29, 2005
February 9, 2010
November 2001
August 2003   (Final data collection date for primary outcome measure)
The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
Same as current
Complete list of historical versions of study NCT00259428 on ClinicalTrials.gov Archive Site
  • - AF/AFL related symptoms collected at the time of ECG/TTEM recording,
  • - mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM)
  • - time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.
Same as current
Not Provided
Not Provided
 
EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)
EURopean Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)

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.

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

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Atrial Flutter
  • Drug: Dronedarone (SR33589)
    oral administration
    Other Name: Multaq®
  • Drug: placebo
    oral administration
  • Experimental: Dronedarone 400mg bid
    dronedarone 400mg tablets
    Intervention: Drug: Dronedarone (SR33589)
  • Placebo Comparator: Placebo
    matching placebo tablets
    Intervention: Drug: placebo
Singh BN, Connolly SJ, Crijns HJ, Roy D, Kowey PR, Capucci A, Radzik D, Aliot EM, Hohnloser SH; EURIDIS and ADONIS Investigators. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med. 2007 Sep 6;357(10):987-99.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
615
August 2003
August 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

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 which increase the risk of severe antiarrhythmic drug side effects, Severe associated conditions.

Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Spain,   United Kingdom
 
 
NCT00259428
EFC3153
SR33589B
Yes
Not Provided
Not Provided
ICD study director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD Clinical study director (CSD) Sanofi
Sanofi
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP