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)
CompletadoFase 3ClinicalTrials.gov
ID: NCT00489736Tipo: INTERVENTIONALInicio: 1 de jun de 2007Fin estimado: 1 de oct de 2008
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.
Elegibilidad
Edad mínima: 21 YearsSexo: ALL
Criterios de inclusión
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
Criterios de exclusión
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.
Intervenciones
drug
dronedarone (SR33589)
oral administration
drug
amiodarone
oral administration
Ubicaciones
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Patrocinadores
PrincipalSanofi
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