European Study of Dronedarone in Atrial Fibrillation (ERATO)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00697086
First received: June 12, 2008
Last updated: July 28, 2009
Last verified: July 2009
  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 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

  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
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 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
Investigators
Study Director: ICD Sanofi
  More Information

Additional Information:
Publications:
Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on October 22, 2014