NCT00259428

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 615 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

Type	Name	Description
DRUG	Dronedarone (SR33589)	oral administration
DRUG	placebo	oral administration

Timeline

• Start date: 2001-11-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2005-11-29
• Last updated: 2010-02-09

Locations

12 sites across 12 countries: Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom