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

This study has been completed.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00259428
  Purpose

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

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

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


Condition Intervention Phase
Atrial Fibrillation
Atrial Flutter
Drug: dronedarone (SR33589)
Drug: placebo
Phase III

Genetics Home Reference related topics:   Brugada syndrome    familial atrial fibrillation    short QT syndrome   

MedlinePlus related topics:   Arrhythmia   

ChemIDplus related topics:   Dronedarone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   EURopean Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence

Secondary Outcome Measures:
  • - 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.

Enrollment:   615
Study Start Date:   November 2001
Study Completion Date:   August 2003
Primary Completion Date:   August 2003 (Final data collection date for primary outcome measure)

Detailed 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

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259428

Locations
Belgium
Sanofi-Aventis Administrative Office    
      Diegem, Belgium
Czech Republic
Sanofi-Aventis Administrative Office    
      Praha, Czech Republic
Denmark
Sanofi-Aventis Administrative Office    
      Horsholm, Denmark
Finland
Sanofi-Aventis Administrative Office    
      Helsinki, Finland
France
Sanofi-Aventis Administrative Office    
      Paris, France
Germany
Sanofi-Aventis Administrative Office    
      Berlin, Germany
Hungary
Sanofi- Aventis Administrative Office    
      Budapest, Hungary
Italy
Sanofi-Aventis Administrative Office    
      Milano, Italy
Netherlands
Sanofi-Aventis Administrative Office    
      Gouda, Netherlands
Poland
Sanofi-Aventis Administrative Office    
      Warszawa, Poland
Spain
Sanofi-Aventis Administrative Office    
      Barcelona, Spain
United Kingdom
Sanofi-Aventis Administrative Office    
      Guildford, United Kingdom

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Study Director:     ICD CSD     Sanofi-Aventis    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Responsible Party:   sanofi-aventis ( ICD study director )
Study ID Numbers:   EFC3153, SR33589B
First Received:   November 25, 2005
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00259428
Health Authority:   United States: Food and Drug Administration;   Germany: Ethics Commission;   Denmark: Danish Medicines Agency

Keywords provided by Sanofi-Aventis:
Atrial Fibrillation  
Atrial Flutter  
Arrhythmia  
Anti-Arrhythmia agents  

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 06, 2008




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