Clinical trial NCT00697086: European Study of Dronedarone in Atrial Fibrillation
Official title: Efficacy and Safety of Dronedarone for the Control of Ventricular Rate During Atrial Fibrillation (ERATO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Heart disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 174
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in mean ventricular rate at rest and during exercise
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Diegem
country: Belgium
facility: Sanofi-aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-aventis Administrative Office
city: Paris
country: France
facility: Sanofi-aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-aventis Administrative Office
city: Warszawa
country: Poland
facility: Sanofi-aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-aventis Administrative Office
city: Geneva
country: Switzerland
facility: Sanofi-aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD
role: STUDY_DIRECTOR
References:
citation: 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 ventricular rate during atrial fibrillation (ERATO) study. Am Heart J. 2008 Sep;156(3):527.e1-9. doi: 10.1016/j.ahj.2008.06.010.