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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
645
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
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Lysaker, Norway
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
...and 5 more locations
Change in HDL-C and triglyceride levels
Time frame: From baseline to end of treatment
Waist circumference and body weight
Time frame: At each visit
Glycemic parameters : FPG, fasting insulinemia, HbA1c,
Time frame: Prior to baseline, month 3, month 6 and month 12.
Lipid parameters : Total Cholesterol, HDL-C, LDL-C, triglyceride levels
Time frame: Prior to baseline, month 3, month 6 and month 12.
Inflammatory parameter : Hs-CRP
Time frame: Prior to baseline, month 3, month 6 and month 12.
Quality of life : IWQOL questionnaire completed
Time frame: At baseline, month 3, month 6, month 9 and month 12.
Incidence of adverse events in each group, including neuro-psychiatric adverse events
Time frame: Prior to baseline, month 3, month 6 and month 12.
Standard laboratory assessments
Time frame: Prior to baseline and month 12
In selected sites, a sub study will be conducted in which additional Lipid parameters will be measured: HDL subfractions, Apo A1, Apo A2, Apo B and Apo C3, Lp A1, LpA1/A2, Lp(a), Oxidized-LDL and LDL size
Time frame: Prior to baseline and at month 12
In selected sites, a sub study will be conducted in which additional Inflammatory parameters will be measured: Adiponectin-High Molecular Weight, Intracellular adhesion molecule 1(ICAM-I) and TNFalpha.
Time frame: Prior to baseline and at month 12
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