drugset / Trial / NCT01135017
Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dronedarone | Small molecule | 400 mg | Oral |