European Study of Dronedarone in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— ERATO  

Official title:

Efficacy and Safety of Dronedarone for the Control of Ventricular Rate During Atrial Fibrillation (ERATO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697086
• Other study ID #: EFC4508
• Secondary ID: SR33589
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2008
• Last updated: July 28, 2009
• Start date: August 2002
• Est. completion date: June 2004

Study information

• Verified date: July 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Dronedarone (SR33589)

• Placebo

Locations

Country	Name	City	State
Belgium	Sanofi-aventis Administrative Office	Diegem
Czech Republic	Sanofi-aventis Administrative Office	Praha
France	Sanofi-aventis Administrative Office	Paris
Italy	Sanofi-aventis Administrative Office	Milano
Netherlands	Sanofi-aventis Administrative Office	Gouda
Poland	Sanofi-aventis Administrative Office	Warszawa
Spain	Sanofi-aventis Administrative Office	Barcelona
Sweden	Sanofi-aventis Administrative Office	Bromma
Switzerland	Sanofi-aventis Administrative Office	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Italy,  Netherlands,  Poland,  Spain,  Sweden,  Switzerland, 

References & Publications (1)

Davy JM, Herold M, Hoglund C, Timmermans A, Alings A, Radzik D, Van Kempen L; ERATO Study Investigators. Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricula — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean ventricular rate at rest and during exercise		Day 14	No

External Links

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