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

NCT01135017 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2013-04-11

Study results available
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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.

Conditions

Interventions

DRUG

Dronedarone

Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)

DRUG

Placebo (for Dronedarone)

Film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner)

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01135017 on ClinicalTrials.gov