NCT00489736|CompletedPhase 3ResultsDMC

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

DIONYSOS

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)

Sanofi ClinicalTrials.gov

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1 other identifier

EFC4968

Study Type

interventional

Target

504

Locations

21 countries

Sites

Timeline

RegisteredJun 2007

StartedJun 2007

CompletionOct 2008

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

504

participants targeted

Target at P50-P75 for phase_3 atrial-fibrillation

Timeline

Completed

Started Jun 2007

Shorter than P25 for phase_3 atrial-fibrillation

Geographic Reach

21 countries

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

June 1, 2007

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

November 9, 2009

Completed

Last Updated

February 18, 2010

Status Verified

February 1, 2010

Enrollment Period

1.3 years

First QC Date

June 20, 2007

Results QC Date

September 30, 2009

Last Update Submit

February 15, 2010

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillationsinus rhythmamiodarone

Outcome Measures

Primary Outcomes (1)

Treatment Failure
The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The "Measured Values" table below presents the numbers of patients with the event at the end of the study period.
minimum study duration is 6 months (+10 days); maximum is 15 months

Secondary Outcomes (1)

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

Other Outcomes (1)

Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting
minimum study duration is 6 months (+10 days); maximum is 15 months

Study Arms (2)

Dronedarone 400mg bid

EXPERIMENTAL

dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg

Drug: dronedarone (SR33589)

Amiodarone 600mg/200mg od

ACTIVE COMPARATOR

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

Interventions

dronedarone (SR33589)DRUG

oral administration

Also known as: Multaq®

Dronedarone 400mg bid

amiodaroneDRUG

oral administration

Amiodarone 600mg/200mg od

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.