European Study of Dronedarone in Atrial Fibrillation (ERATO)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00697086
First received: June 12, 2008
Last updated: July 28, 2009
Last verified: July 2009
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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:
Genetics Home Reference related topics:
familial atrial fibrillation
Drug Information available for:
Dronedarone
U.S. FDA Resources
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
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 Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013