European Study of Dronedarone in Atrial Fibrillation (ERATO)

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: June 12, 2008
Last updated: July 28, 2009
Last verified: July 2009
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Dronedarone for the Control of Ventricular Rate During Atrial Fibrillation (ERATO)

Resource links provided by NLM:

Further study details as provided by Sanofi:

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
Experimental: 1 Drug: Dronedarone (SR33589)
Placebo Comparator: 2 Drug: Placebo


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00697086

Sanofi-aventis Administrative Office
Diegem, Belgium
Czech Republic
Sanofi-aventis Administrative Office
Praha, Czech Republic
Sanofi-aventis Administrative Office
Paris, France
Sanofi-aventis Administrative Office
Milano, Italy
Sanofi-aventis Administrative Office
Gouda, Netherlands
Sanofi-aventis Administrative Office
Warszawa, Poland
Sanofi-aventis Administrative Office
Barcelona, Spain
Sanofi-aventis Administrative Office
Bromma, Sweden
Sanofi-aventis Administrative Office
Geneva, Switzerland
Sponsors and Collaborators
Study Director: ICD Sanofi
  More Information

Additional Information:
Responsible Party: International Clinical Development Study Director, sanofi-aventis Identifier: NCT00697086     History of Changes
Other Study ID Numbers: EFC4508  SR33589 
Study First Received: June 12, 2008
Last Updated: July 28, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Heart disease

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on May 02, 2016