drugset / Trial / NCT01135017

Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers

NCT01135017

Phase 4 Terminated 112 enrolled Sanofi
RandomizedParallel-groupTriple-blindTreatment

Summary

Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker. Secondary objectives were to evaluate: * the effects of dronedarone on AF pattern characteristics i.e. ventricular rate during AF; * the effects of dronedarone on subject-perceived AF burden and symptom severity as reported by subjects using the Atrial Fibrillation Severity Scale (AFSS); * the incidence of electrical cardioversion (or overdrive pacing) during treatment; * the safety of dronedarone.

Timeline

Start
2010-07
Primary completion
2012-02
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Dronedarone Small molecule 400 mg Oral

Indications