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
Results First Received: September 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Drug: dronedarone (SR33589)
Drug: amiodarone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment of patients started on June 12, 2007 and was completed on October 3, 2008. The study was conducted in 112 centers in 23 countries. Minimum duration of treatment was 6 months. Minimum duration of observation was last patient's randomization plus 190 days.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Planned sample size was 472. Six hundred and eighteen patients (618) were screened of which 113 did not verify one or more selection criteria. One eligible patient received a placebo capsule (morning intake in the amiodarone group) but was not randomized in the trial. This patient did not report any adverse event and was excluded from all analyses.

Reporting Groups
  Description
Dronedarone 400mg Bid dronedarone tablets 400mg twice daily (bid)
Amiodarone 600mg/200mg od amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)

Participant Flow:   Overall Study
    Dronedarone 400mg Bid     Amiodarone 600mg/200mg od  
STARTED     249 [1]   255 [1]
COMPLETED     153 [2]   186 [2]
NOT COMPLETED     96     69  
Lack of Efficacy                 53                 14  
Adverse Event                 32                 45  
Poor compliance                 6                 2  
Not coded/ Not pre-specified                 5                 8  
[1] Randomized and treated patients
[2] completed study drug period



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Dronedarone 400mg Bid dronedarone tablets 400mg twice daily (bid)
Amiodarone 600mg/200mg od amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
Total Total of all reporting groups

Baseline Measures
    Dronedarone 400mg Bid     Amiodarone 600mg/200mg od     Total  
Number of Participants  
[units: participants]
  249     255     504  
Age, Customized  
[units: participants]
     
18 to < 65 years     125     138     263  
65 to < 75 years     76     70     146  
>= 75 years     48     47     95  
Age  
[units: years]
Mean ± Standard Deviation
  64.4  ± 10.8     63.7  ± 10.6     64.0  ± 10.7  
Gender  
[units: participants]
     
Female     73     73     146  
Male     176     182     358  



  Outcome Measures
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1.  Primary:   Treatment Failure   [ Time Frame: minimum study duration is 6 months (+10 days); maximum is 15 months ]

2.  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   [ Time Frame: minimum study duration is 6 months (+10 days); maximum is 15 months ]

3.  Other Pre-specified:   Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting   [ Time Frame: minimum study duration is 6 months (+10 days); maximum is 15 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: International Clinical Development, Clinical Study Director
Organization: sanofi-aventis
e-mail: GV-Contact-us@sanofi-aventis.com


No publications provided by Sanofi

Publications automatically indexed to this study:

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)