Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00489736
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : November 9, 2009
Last Update Posted : February 18, 2010
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE June 20, 2007
First Posted Date  ICMJE June 21, 2007
Results First Submitted Date  ICMJE September 30, 2009
Results First Posted Date  ICMJE November 9, 2009
Last Update Posted Date February 18, 2010
Study Start Date  ICMJE June 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
Treatment Failure [ Time Frame: minimum study duration is 6 months (+10 days); maximum is 15 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2007)
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
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2007)
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: dronedarone (SR33589)
    oral administration
    Other Name: Multaq®
  • Drug: amiodarone
    oral administration
Study Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: September 30, 2009)
504
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2007)
472
Actual Study Completion Date  ICMJE October 2008
Actual 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00489736
Other Study ID Numbers  ICMJE EFC4968
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account Sanofi
Verification Date February 2010

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