PATIENTS WITH ABDOMINAL OBESITY AND ADDITIONAL CARDIOMETABOLIC RISK FACTORS MedDRA version: 8.1 Level: LLT Classification code 10059179 Term: Abdominal obesity
Conditions
Sponsors
sanofi aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Informed consent must be obtained in writing for all patients at enrollment into the study 2) Male or female 35-65 years of age 3) Females must be post-menopausal (menopause is defined as 6 months of amenorrhea and plasma FSH > 20 U/L) 4) BMI > 27 kg/m² and 88 cm in women; > 102 cm in men. 7) With at least one lipid abnormality defined as: - Fasting Triglycerides level >1.7 mmol/L (150 mg/dL) and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) HDL 155 mg/dl (4.00 mmol/L) or total cholesterol 250 mg/dl (> 6.5mmol/L) or genetic hyperlipidaemia 3) Fasting triglycerides > 400 mg/dL (4.5 mmol/L) 4) Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia) 5) ApoE2/E2 homozygosity, Apo E4/E4 homozygosity 6) Type 2 diabetes treated with oral agents and/or insulin 7) Diet treated type 2 diabetic patients with HbA1c = 7% 8) History of cardio vascular disease (myocardial infarction, angina, stroke, confirmed peripheral arterial disease, coronary and peripheral vascular Surgery (CABG, PCI…) 9) Systolic blood pressure = 160 mm Hg or diastolic blood pressure = 95 mm Hg 10) Very low-calorie diet (1200 calories a day or less) or history of surgical procedures for weight loss (e.g., stomach stapling, bypass) 11) Body weight fluctuation > 5 Kg during the previous 3 months 12) History of bulimia or anorexia nervosa by DSM-IV criteria 13) Presence of any clinically significant endocrine disease according to the investigator, Cushing syndrome, obesity secondary to hypothalamic/pituitary disorder 14) Abnormal TSH and free T4 at baseline (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status) 15) Severe hepatic impairment known by the investigator or AST or ALT > 3 times the ULN at screening. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the patient must not be included in the study 16) Known severe renal dysfunction (creatinine clearance < 30 ml/min) or urine analysis (performed at screening by dipstick) showing 2+ or more protein 17) Presence of any condition (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient safety or limit his/her successful participation to the study: • Any current malignancy or any cancer within the past five years (except adequately treated basal cell skin cancer or cervical carcinoma in situ) • Any history of cardiac failure • Relevant acute abnormal finding seen on ECG • Significant haematology abnormalities (haemoglobin < 120 g/L and/or neutrophils < 1.5 G/L and/or platelets < 100 G/L) 18) Patient treated for epilepsy 19) Uncontrolled serious psychiatric illness such as a major depression 20) History of alcohol and/or drug abuse 21) Smoker or smoking cessation within the past 3 months 22) Marijuana or hashish users 23) Previous participation in a Rimonabant study or to any other clinical trial within 4 weeks to study start 24) Hypersensitivity/intolerance to the active substance or to any of the excipients such as lactose 25) Blood donation within the past 3 months prior to the study or planned during the study or within the 3 months from the study completing 26) History of peptic ulcer 27) Willebrand disease or other hemorrhagic diatheses Concomitant medications prior and during the study: 28) Administration of any of the following within 3 months prior to screening visit and susceptible to be prescribed during the study treatment period: - Lipid-lowering drugs intake (statin, fibrate, bile acid sequestrant, ezetimibe, nicotinic acid) - Other drugs for weight reduction (phentermine, amphetamines) - Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Primary End-point is the fractional catabolic rate of ApoA-I in HDL after 12 months of treatment. ;Secondary Objective: - To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other lipoprotein kinetics. - To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters - To assess effect of Rimonabant on body composition - To assess safety of Rimonabant;Primary end point(s): The primary end point is the fractional catabolic rate (FCR) of ApoA-1 in HDL after 12 months of treatment. | — |
Countries
Finland, France, United Kingdom
Outcome results
None listed