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ETERNAL
A European Randomized, Parallel Group, Two-arm Placebo-controlled, Double-blind Multicenter Study of Rimonabant 20mg Once Daily in the Treatment of Abdominally Obese Patients With Dyslipidemia With or Without Other Comorbidities
Sponsor study identifier
Secondary identifiers
interventional
645
15 countries
15
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)Study Completion
January 2009
Actual (reported)Primary : To determine the effect of Rimonabant 20 mg on changes in, HDL-Cholesterol (HDL-C), triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities. Main Secondary : To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients. In selected sites, a sub study will be conducted to determine the effect of 12 months of Rimonabant on additional lipoprotein and inflammatory parameters.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 15, 2006
Actual (reported)December 18, 2006
Actual (reported)January 2009
Actual (reported)January 2009
Actual (reported)Change in HDL-C and triglyceride levels
From baseline to end of treatment
Waist circumference and body weight
At each visit
Glycemic parameters : FPG, fasting insulinemia, HbA1c,
Prior to baseline, month 3, month 6 and month 12.
Lipid parameters : Total Cholesterol, HDL-C, LDL-C, triglyceride levels
Prior to baseline, month 3, month 6 and month 12.
Inflammatory parameter : Hs-CRP
Prior to baseline, month 3, month 6 and month 12.
Quality of life : IWQOL questionnaire completed
At baseline, month 3, month 6, month 9 and month 12.
Administration of one tablet containing 20 mg of active rimonabantonce daily in the morning. White film-coated tablets, for oral administration containing 20 mg of active rimonabant
Administration of one rimonabant placebo tablet once daily in the morning. Undistinguishable placebo tablets.
Sanofi-Aventis Administrative Office
Prague, Czechia
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Athens, Greece
Sanofi-Aventis Administrative Office
Budapest, Hungary
Sanofi-Aventis Administrative Office
Dublin, Ireland
Sanofi-Aventis Administrative Office
Milan, Italy
Valérie Pilorget, MD
Sanofi
645 participants (actual enrollment reported by the registry).
First Submitted
December 15, 2006
First Posted
December 18, 2006
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Lysaker, Norway
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Sanofi-Aventis Administrative Office
Bratislava, Slovakia
Sanofi-Aventis Administrative Office
Stockholm, Sweden
Sanofi-Aventis Administrative Office
Meyrin, Switzerland
Sanofi-Aventis Administrative Office
Istanbul, Turkey (Türkiye)
Sanofi-Aventis Administrative Office
Guildford, United Kingdom
Primary Completion
January 2009
Actual (reported)Study Completion
January 2009
Actual (reported)Last Updated
December 10, 2010
Record last verified: 2010-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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