CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,628 enrolled
Drug / intervention
dronedarone (SR33589) +1 moredrug
Likely dose
Dronedarone 400 mg orally twice dailyAI-extracted
Key inclusion· 3
  • ✓Age ≥75 years, or age ≥70 years with at least one cardiac risk factor (hypertension on ≥2 drug classes, diabetes, prior stroke/TIA/systemic embolism, left atrium ≥50 mm, or LVEF <0.40)
  • ✓One ECG within last 6 months documenting AF/AFL
  • ✓One ECG within last 6 months documenting sinus rhythm
Key exclusion· 9
  • ✕Permanent atrial fibrillation
  • ✕Hemodynamic instability: acute pulmonary edema within 12 hours, cardiogenic shock, IV pressor agents, mechanical ventilation, NYHA IV heart failure within 4 weeks, hemodynamically significant valvular disease or obstructive cardiomyopathy, cardiac surgery/revascularization within 4 weeks
  • ✕Planned major cardiac or non-cardiac surgery, including CABG, PCI, or valvular surgery; or on urgent cardiac transplantation list
  • ✕Acute myocarditis or constrictive pericarditis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00174785
NCT00174785Phase 3Completed
CompareCT.gov

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)

Sanofi·interventional·Posted Sep 15, 2005·Updated Jan 12, 2010

In Brief

A Phase 3 clinical trial evaluating dronedarone (SR33589) and placebo for Atrial Fibrillation and Atrial Flutter. Completed, enrolled 4,628 participants across 37 sites in 37 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Atrial Flutter
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartJun 1, 2005
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.8 years ago

Interventions

dronedarone (SR33589)drug

oral administration (tablets)

placebodrug

oral administration (tablets)