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

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

  • Dronedarone (Multaq)Drug
    Intervention Desc: Mainly for the indication of cardiac arrhythmias (irregular heartbeat).
  • amiodarone Drug
    Intervention Desc: oral administration
    ARM 1: Kind: Experimental
    Label: Amiodarone 600mg/200mg od
    Description: 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
  • Dronedarone (SR33589) Drug
    Other Names: Multaq®
    Intervention Desc: oral administration
    ARM 1: Kind: Experimental
    Label: Dronedarone 400mg bid
    Description: dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg

Trial Design

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

Patient Involvement

Patients will be randomized to one of two arms 1)Experimental arm and given dronedarone (SR33589) 400mg bid or 2) Active Comparator and given amiodarone 600mg daily for 28 days, then 200mg daily. Patients are then followed for 6 months to evaluate outcomes.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary efficacy endpoint is treatment failure defined as recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy.
Secondary 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.
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

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