European Study of Dronedarone in Atrial Fibrillation (ERATO)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: Placebo; Drug: Dronedarone (SR33589)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697086

SR33589

EFC4508

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Dronedarone (SR33589)

2

Placebo Comparator group

Treatment:

Drug: Placebo