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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00259428
First received: November 25, 2005
Last updated: February 8, 2010
Last verified: February 2010

November 25, 2005
February 8, 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Both
21 Years and older
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
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