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European Study of Dronedarone in Atrial Fibrillation (ERATO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00697086
First Posted: June 13, 2008
Last Update Posted: July 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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
Intervention Model: Parallel Assignment
Masking: Double
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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00697086     History of Changes
Other Study ID Numbers: EFC4508
SR33589
First Submitted: June 12, 2008
First Posted: June 13, 2008
Last Update Posted: July 30, 2009
Last Verified: July 2009

Keywords provided by Sanofi:
Heart disease

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors