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European Study of Dronedarone in Atrial Fibrillation (ERATO)

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dronedarone (SR33589)

Placebo

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Heart disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in mean ventricular rate at rest and during exercise

Secondary Outcome Measures

Full Information

NCT ID

NCT00697086

First Posted

June 12, 2008

Last Updated

July 28, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00697086

Brief Title

European Study of Dronedarone in Atrial Fibrillation

Acronym

ERATO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

August 2002 (undefined)

Primary Completion Date

June 2004 (Actual)

Study Completion Date

June 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Heart disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Dronedarone (SR33589)

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change from baseline in mean ventricular rate at rest and during exercise

Time Frame

Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name