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.
Official Title
Randomized DB Trial to Evaluate Efficacy & 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
Conditions
Atrial Fibrillation
Study Type
Interventional
Study Design
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Further Details
- Primary Outcome Measures: 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 Outcome Measures: 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.
Study Start
June 2007
Eligibility & Criteria
- Ages Eligible for Study: 21 Years and above
- Genders Eligible for Study: Both
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
- Women of childbearing potential or pregnant or breastfeeding
- Atrial flutter
- Paroxysmal atrial fibrillation
- Contraindication to amiodarone
The above information is not intended to contain all considerations relevant to a patient’s potential participation in a clinical trial.
Total Enrolment
472
Contact Details
Sanofi-Aventis Administrative Office, Cove, New South Wales, Australia; Recruiting
- GV-Contact-us@sanofi-aventis.com
- Sanofi-Aventis
All content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.
Related Articles
Need a health appointment?
Find and book a doctor, dentist, physio and more on Healthengine
Find a practitioner
