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

Atrial Fibrillation Clinical Trial

— DIONYSOS  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489736
• Other study ID #: EFC4968
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2007
• Last updated: February 15, 2010
• Start date: June 2007
• Est. completion date: October 2008

Study information

• Verified date: February 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaNetherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• dronedarone (SR33589)
oral administration
• amiodarone
oral administration

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Australia	Sanofi-Aventis Administrative Office	Cove
Austria	Sanofi-Aventis Administrative Office	Vienna
Belgium	Sanofi-Aventis Administrative Office	Diegem
Canada	Sanofi-Aventis Administrative Office	Laval
Chile	Sanofi-Aventis Administrative Office	Santiago
China	Sanofi-Aventis Administrative Office	Shangaï
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Estonia	Sanofi-Aventis Administrative Office	Tallinn
Finland	Sanofi-Aventis Administrative Office	Helsinki
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Italy	Sanofi-Aventis Administrative Office	Milan
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul
Mexico	Sanofi-Aventis Administrative Office	Mexico
Morocco	Sanofi-Aventis Administrative Office	Casablanca
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Poland	Sanofi-Aventis Administrative Office	Warszawa
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Sweden	Sanofi-Aventis Administrative Office	Bromma
Tunisia	Sanofi-Aventis Administrative Office	Megrine
Turkey	Sanofi-Aventis Administrative Office	Istanbul
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Failure		minimum study duration is 6 months (+10 days); maximum is 15 months	No
Secondary	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		minimum study duration is 6 months (+10 days); maximum is 15 months	Yes