Abdominally obese patients with atherogenic dyslipidemia MedDRA version: 7.1 Level: LLT Classification code 10058110
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients aged =18 years • Waist circumference > 102 cm in men and > 88 cm in women • Dyslipidemia consisting of: - Triglyceridemia = 1.50g/L (i.e. 1.69mmol/L) and = 7.0g/L (i.e. 7.90mmol/L) AND/OR - HDL cholesterol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Weight change > 5 kg within 3 months prior to screening visit • Pregnancy or lactation, or women planning to become pregnant • Absence of medically approved contraceptive methods for females of childbearing potential1 • Marijuana or hashish users • Presence of any other condition (e.g. geographic, social…) actual or anticipated, that the Investigator feels that would restrict or limit the subject’s participation for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of rimonabant on HDL cholesterol and on triglyceride plasma levels over a period of one year when precribed with a hypocaloric diet in abdominally obese patients with atherogenic dyslipidemia.;Secondary Objective: • To assess the effect of rimonabant over a period of 1 year on: -Specific lipid parameters, hs-CRP -Adipokines: Adiponectin, Leptin -Fasting glycemia and insulinemia, HbA1c -Waist circumference -Weight -Visceral and liver fat measured using CT scan (in selected sites) • To evaluate the safety and tolerability of rimonabant;Primary end point(s): Two co-primary efficacy endpoints: Relative change from baseline to Month 12 in plasma HDL cholesterol and relative change from baseline in plasma triglyceride levels. | — |
Countries
Denmark, Italy, Sweden
Outcome results
None listed