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European Study of Dronedarone in Atrial Fibrillation

NCT ID: NCT00697086

Last Updated: 2009-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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Heart disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type EXPERIMENTAL

Dronedarone (SR33589)

Intervention Type DRUG

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Dronedarone (SR33589)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-aventis Administrative Office

Diegem, , Belgium

Site Status

Sanofi-aventis Administrative Office

Prague, , Czechia

Site Status

Sanofi-aventis Administrative Office

Paris, , France

Site Status

Sanofi-aventis Administrative Office

Milan, , Italy

Site Status

Sanofi-aventis Administrative Office

Gouda, , Netherlands

Site Status

Sanofi-aventis Administrative Office

Warsaw, , Poland

Site Status

Sanofi-aventis Administrative Office

Barcelona, , Spain

Site Status

Sanofi-aventis Administrative Office

Bromma, , Sweden

Site Status

Sanofi-aventis Administrative Office

Geneva, , Switzerland

Site Status

Countries

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Belgium Czechia France Italy Netherlands Poland Spain Sweden Switzerland

References

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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.

Reference Type RESULT
PMID: 18760136 (View on PubMed)

Related Links

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http://www.sanofi-aventis.com

Related Info

Other Identifiers

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SR33589

Identifier Type: -

Identifier Source: secondary_id

EFC4508

Identifier Type: -

Identifier Source: org_study_id