Randomized, double-blind, two -arms placebo-controlled, parallel-group, multicenter study of rimonabant 20 mg once daily in the treatment of atherogenic dyslipidemia in abdominally obese patients. - ADAGIO-Lipids

Conditions: Abdominally obese patients with atherogenic dyslipidemia
MedDRA version: 7.1Level: LLTClassification code 10058110

Registration Number: EUCTR2005-000807-33-SE

Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 740

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 < 50mg/dL (1.29mmol/L) in women and < 40mg/dL (1.04mmol/L)
in men
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>-Specific lipid parameters, hs-CRP<br>-Adipokines: Adiponectin, Leptin<br>-Fasting glycemia and insulinemia, HbA1c<br>-Waist circumference<br>-Weight<br>-Visceral and liver fat measured using CT scan (in selected sites)<br><br>• To evaluate the safety and tolerability of rimonabant;Primary end point(s): Two co-primary efficacy endpoints:<br>Relative change from baseline to Month 12 in<br>plasma HDL cholesterol and relative change<br>from baseline in plasma triglyceride levels.

Secondary Outcome Measures