Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: dronedarone (SR33589) (Drug); amiodarone (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
ICD CSD, Study Director, Affiliation: Sanofi-Aventis
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.
Clinical Details
Official title: 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)
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sanofi-Aventis Administrative Office, Buenos Aires, Argentina
Sanofi-Aventis Administrative Office, Cove, Australia
Sanofi-Aventis Administrative Office, Vienna, Austria
Sanofi-Aventis Administrative Office, Diegem, Belgium
Sanofi-Aventis Administrative Office, Laval, Canada
Sanofi-Aventis Administrative Office, Santiago, Chile
Sanofi-Aventis Administrative Office, Shangaï, China
Sanofi-Aventis Administrative Office, Praha, Czech Republic
Sanofi-Aventis Administrative Office, Tallinn, Estonia
Sanofi-Aventis Administrative Office, Helsinki, Finland
Sanofi-Aventis Administrative Office, Paris, France
Sanofi-Aventis Administrative Office, Berlin, Germany
Sanofi-Aventis Administrative Office, Milan, Italy
Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of
Sanofi-Aventis Administrative Office, Mexico, Mexico
Sanofi-Aventis Administrative Office, Casablanca, Morocco
Sanofi-Aventis Administrative Office, Gouda, Netherlands
Sanofi-Aventis Administrative Office, Warszawa, Poland
Sanofi-Aventis Administrative Office, Moscow, Russian Federation
Sanofi-Aventis Administrative Office, Bromma, Sweden
Sanofi-Aventis Administrative Office, Megrine, Tunisia
Sanofi-Aventis Administrative Office, Istanbul, Turkey
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey 08807, United States
Additional Information
Starting date: June 2007
Ending date: September 2008
Last updated: June 2, 2008
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