Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (DIONYSOS)

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00489736

First received: June 20, 2007

Last updated: February 15, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 20, 2007

Last Updated Date

February 15, 2010

Start Date ^ICMJE

June 2007

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Treatment Failure [ Time Frame: minimum study duration is 6 months (+10 days); maximum is 15 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary efficacy endpoint is treatment failure defined as recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy.

Change History

Complete list of historical versions of study NCT00489736 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event [ Time Frame: minimum study duration is 6 months (+10 days); maximum is 15 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

The main safety endpoint is occurrence of Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye or Gastrointestinal specific events or premature study drug discontinuation following any adverse event.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

Official Title ^ICMJE

Randomized Double Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF)

Brief Summary

The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: dronedarone (SR33589)
oral administration

Other Name: Multaq®
Drug: amiodarone
oral administration

Study Arm (s)

Experimental: Dronedarone 400mg bid
dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg

Intervention: Drug: dronedarone (SR33589)
Active Comparator: Amiodarone 600mg/200mg od
over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets

Intervention: Drug: amiodarone

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

504

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation

Exclusion Criteria:

Contraindication to oral anticoagulation
Patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous)
Patients known to have chronic AF, patients with atrial flutter or paroxysmal atrial fibrillation
Severe congestive heart failure with New-York Heart Association (NYHA) class III or IV, severe bradycardia, high degree atrio-ventricular block, ongoing potentially dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator, first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease, significant sinus node disease without a permanent pacemaker implanted
History of torsades de pointes or long QT syndrome or QT- or QTc-interval ≥500 msecs before randomization
Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued
Dysthyroidism or other contraindication to amiodarone

The above information are not intended to contain all the considerations relevant to a patient's potential participation in a clinical trial.

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czech Republic, Estonia, Finland, France, Germany, Italy, Korea, Republic of, Mexico, Morocco, Netherlands, Poland, Russian Federation, Sweden, Tunisia, Turkey

Administrative Information

NCT Number ^ICMJE

NCT00489736

Other Study ID Numbers ^ICMJE

EFC4968

Has Data Monitoring Committee

Yes

Responsible Party

International Clinical Development, Clinical Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

International Clinical Development

Sanofi

Information Provided By

Sanofi

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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