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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00174785 |
The primary efficacy parameter is the combined endpoint of cardiovascular hospitalization and death. Secondary efficacy parameters are death of any cause, cardiovascular death, cardiovascular hospitalization and non-cardiovascular hospitalization.
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation Atrial Flutter |
Drug: dronedarone (SR33589) Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Placebo-Controlled,Double-Blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in patiENts With Atrial Fibrillation/Atrial Flutter (AF/AFL) |
Enrollment: | 4628 |
Study Start Date: | June 2005 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: dronedarone (SR33589) |
2: Placebo Comparator | Drug: placebo |
This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone 400 mg BID versus placebo (ratio 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be included in the study while in atrial fibrillation/flutter or in sinus rhythm if conversion has occurred either spontaneously or following a procedure such as electrical cardioversion (or overdrive pacing) or administration of an antiarrhythmic drug.After randomization all patients will be followed until the common study end date; the last patient included in the study will be followed for 1 year. Visits will be at baseline, after 7 days, after 14 days, after one month, after three months and then every three months until end of the study. At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit. The study wil be monitored by an independent DMC for safety, tolerability and efficacy.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Patients aged 75 years or older, or patients aged at least 70 years with one or more of the following risk factors at baseline:
Exclusion Criteria:
General criteria:
Criteria Related to a cardiac condition:
Criteria Related to Concomitant Medications:
Criteria Related to Laboratory Abnormalities:
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC5555 |
Study First Received: | September 13, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00174785 |
Health Authority: | United States: Food and Drug Administration; Netherlands: Medicines Evaluation Board (MEB); France: Afssaps - French Health Products Safety Agency |
Mortality, Hospitalization |
Death Heart Diseases Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |