European Study of Dronedarone in Atrial Fibrillation | NCT00697086

Studies
European Study of Dronedarone in Atrial Fibrillation

NCT00697086

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jul 30, 2009Estimated

Enrollment

174Actual

Phase

Phase 3

Conditions

Atrial Fibrillation

Interventions

Dronedarone (SR33589)
Placebo

Countries

Belgium
Czechia
France
Italy
Netherlands
Poland
Spain
Sweden
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SR33589

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2002

Primary Completion Date

Jun 2004Actual

Completion Date

Jun 2004Actual

First Submitted Date

Jun 12, 2008

First Submission Date that Met QC Criteria

Jun 12, 2008

First Posted Date

Jun 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2009

Last Update Posted Date

Jul 30, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

174Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: Dronedarone (SR33589)
2	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Dronedarone (SR33589)	Drug		1
Placebo

Measure	Description	Time Frame
Change from baseline in mean ventricular rate at rest and during exercise		Day 14

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
ICD	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-aventis Administrative Office		Diegem			Belgium
Sanofi-aventis Administrative Office

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18760136	Result	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.

ID	Term
D001281	Atrial Fibrillation
D006331	Heart Diseases

ID	Term
D001145	Arrhythmias, Cardiac
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000638	Amiodarone
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring