drugset / Trial / NCT00259428

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

NCT00259428

Phase 3 Completed 615 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2001-11
Primary completion
2003-08
Completion
2003-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Dronedarone Small molecule 400 mg Oral