A RANDOMIZED, DOUBLE BLIND, TWO ARM, PARALLEL, PLACEBO CONTROLLED STUDY OF RIMONABANT 20MG EFFECT ON HIGH DENSITY LIPOPROTEIN KINETICS IN PATIENTS WITH ABDOMINAL OBESITY AND ADDITIONAL CARDIOMETABOLIC RISK FACTORS - HDL TURNOVER

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

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 < 40 kg/m²
5)Willingness and ability to comply with the study protocol
6)Men or women with abdominal obesity according to NCEP/ATPIII criteria: Waist Circumference > 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 < 4.5 mmol/L (400 mg/dL)
- HDL < 1.03 mmol/L (40 mg/dL) in men and < 1.29 mmol/L (50 mg/dL) in women

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) HDL< or = 0.60 mmol/L (23 mg/dl)
2)Plasma LDL-Cholesterol > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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