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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00696631 |
The purpose of this study is to assess the efficacy, tolerability and safety of dronedarone versus placebo in patients with symptomatic congestive heart failure (CHF) and left ventricular dysfunction (LVD) when added to evidence based treatments for CHF.
Condition | Intervention | Phase |
---|---|---|
Congestive Heart Failure |
Drug: Dronedarone (SR33589) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Antiarrhythmic Trial With Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease |
Enrollment: | 627 |
Study Start Date: | June 2002 |
Study Completion Date: | August 2003 |
Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Dronedarone (SR33589)
400 mg tablets bid
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2: Placebo Comparator |
Drug: Placebo
matching placebo tablets
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Denmark | |
Sanofi-aventis Administrative Office | |
Horsholm, Denmark | |
Hungary | |
Sanofi-aventis Administrative Office | |
Budapest, Hungary | |
Netherlands | |
Sanofi-aventis Administrative Office | |
Gouda, Netherlands | |
Norway | |
Sanofi-aventis Administrative Office | |
Lysaker, Norway | |
Poland | |
Sanofi-aventis Administrative Office | |
Warszawa, Poland | |
Sweden | |
Sanofi-aventis Administrative Office | |
Bromma, Sweden |
Study Director: | ICD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC4966, SR33589 |
Study First Received: | June 12, 2008 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00696631 |
Health Authority: | Denmark: Danish Medicines Agency |
Heart disease morbidity |
Heart Failure Heart Diseases |
Cardiovascular Diseases |