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Trial record 23 of 78 for:    sanofi-aventis and sweden

European Study of Dronedarone in Atrial Fibrillation (ERATO)

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. Identifier: NCT00697086
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : July 30, 2009
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Dronedarone (SR33589) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
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)
Study Start Date : August 2002
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Dronedarone

Arm Intervention/treatment
Experimental: 1 Drug: Dronedarone (SR33589)
Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. Change from baseline in mean ventricular rate at rest and during exercise [ Time Frame: Day 14 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): NCT00697086

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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
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Study Director: ICD Sanofi

Additional Information:
Publications of Results:
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Responsible Party: International Clinical Development Study Director, sanofi-aventis Identifier: NCT00697086     History of Changes
Other Study ID Numbers: EFC4508
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: July 30, 2009
Last Verified: July 2009
Keywords provided by Sanofi:
Heart disease
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents