NCT00174785

A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation

A Placebo-controlled,Double-blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter (AF/AFL)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,628 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL). To assess that dronedarone is well tolerated in this population.

Detailed description

This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone versus placebo (ratio 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be included in the study while in atrial fibrillation/flutter or in sinus rhythm if conversion has occurred either spontaneously or following a procedure such as electrical cardioversion (or overdrive pacing) or administration of an antiarrhythmic drug.After randomization all patients will be followed until the common study end date; the last patient included in the study will be followed for 1 year. Visits will be at baseline, after 7 days, after 14 days, after one month, after three months and then every three months until end of the study. At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit. The study will be monitored by an independent Data Monitoring Committee (DMC) for safety, tolerability and efficacy.

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

Type	Name	Description
DRUG	dronedarone (SR33589)	oral administration (tablets)
DRUG	placebo	oral administration (tablets)

Timeline

• Start date: 2005-06-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2005-09-15
• Last updated: 2010-01-12
• Results posted: 2009-12-23

Locations

37 sites across 37 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czechia, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey (Türkiye), United Kingdom