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
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: dronedarone (SR33589)
Drug: amiodarone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 504
Study Start Date: June 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dronedarone 400mg bid
dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg
Drug: dronedarone (SR33589)
oral administration
Other Name: Multaq®
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
Drug: amiodarone
oral administration

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489736

  Hide Study Locations
Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Australia
Sanofi-Aventis Administrative Office
Cove, Australia
Austria
Sanofi-Aventis Administrative Office
Vienna, Austria
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
China
Sanofi-Aventis Administrative Office
Shangaï, China
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Estonia
Sanofi-Aventis Administrative Office
Tallinn, Estonia
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Morocco
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Tunisia
Sanofi-Aventis Administrative Office
Megrine, Tunisia
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: International Clinical Development Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Clinical Development, Clinical Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00489736     History of Changes
Other Study ID Numbers: EFC4968
Study First Received: June 20, 2007
Results First Received: September 30, 2009
Last Updated: February 15, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Sanofi:
Atrial Fibrillation
sinus rhythm
amiodarone

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on September 30, 2014