European Study of Dronedarone in Atrial Fibrillation - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00697086

Purpose

The purpose of this study is to assess the efficacy of dronedarone for the control of ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to assess the tolerability of dronedarone in the target population.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Dronedarone (SR33589) Drug: Placebo	Phase III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Exercise and Physical Fitness

Drug Information available for: Dronedarone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy and Safety of Dronedarone for the Control of Ventricular Rate During Atrial Fibrillation

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change from baseline in mean ventricular rate at rest and during exercise [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Enrollment:	174
Study Start Date:	August 2002
Study Completion Date:	June 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Dronedarone (SR33589)
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with symptomatic permanent AF (>6 months) for which cardioversion is not considered and resting ventricular rate > or equal 80 bpm at screening measured on a 6-seconds rhythm strip,

Exclusion Criteria:

Unstable angina pectoris, recent myocardial infarction or history of torsades de pointes
Third degree atrioventricular block at the screening ECG or significant sinus node disease without a permanent pacemaker implanted
Clinically overt congestive heart failure at randomization
Patients treated with amiodarone, other antiarrhythmic drugs or previous participation in this trial or in other dronedarone trials or taking an investigational drug
Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic or psychiatric disease
Pregnant and/or breastfeeding women or women of child-bearing potential with no adequate birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697086

Locations

Belgium
Sanofi-aventis Administrative Office
Diegem, Belgium
Czech Republic
Sanofi-aventis Administrative Office
Praha, Czech Republic
France
Sanofi-aventis Administrative Office
Paris, France
Italy
Sanofi-aventis Administrative Office
Milano, Italy
Netherlands
Sanofi-aventis Administrative Office
Gouda, Netherlands
Poland
Sanofi-aventis Administrative Office
Warszawa, Poland
Spain
Sanofi-aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-aventis Administrative Office
Geneva, Switzerland

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC4508, SR33589
Study First Received:	June 12, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00697086
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

Heart disease

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009