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

June 20, 2007
February 15, 2010
June 2007
October 2008   (final data collection date for primary outcome measure)
Treatment Failure [ Time Frame: minimum study duration is 6 months (+10 days); maximum is 15 months ] [ Designated as safety issue: No ]
The primary efficacy endpoint is treatment failure defined as recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy.
Complete list of historical versions of study NCT00489736 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Atrial Fibrillation
  • Drug: dronedarone (SR33589)
    oral administration
    Other Name: Multaq®
  • Drug: amiodarone
    oral administration
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
504
October 2008
October 2008   (final data collection date for primary outcome measure)

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.

Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT00489736
EFC4968
Yes
International Clinical Development, Clinical Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: International Clinical Development Sanofi
Sanofi
February 2010

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