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

February 8, 2010 updated by: Sanofi

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.

Study Overview

Status

Completed

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

Study Type

Interventional

Enrollment (Actual)

615

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
matching placebo tablets
oral administration
Experimental: Dronedarone 400mg bid
dronedarone 400mg tablets
oral administration
Other Names:
  • Multaq®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence

Secondary Outcome Measures

Outcome Measure
- 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: ICD Clinical study director (CSD), Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

November 25, 2005

First Submitted That Met QC Criteria

November 25, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

February 9, 2010

Last Update Submitted That Met QC Criteria

February 8, 2010

Last Verified

February 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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