High Density Lipoprotein Turnover

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period.

Primary objectives:

• To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR).

Secondary objectives:

• 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Rimonabant

Criteria

Inclusion Criteria:

• Abdominally obese patients with additional cardiometabolic risk factors

• Females must be post-menopausal

• BMI > 27 kg/m² and < 40 kg/m²

• Men or women with abdominal obesity according to NCEP/ATPIII criteria: Waist Circumference > 88 cm in women; > 102 cm in men

• 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

Exclusion Criteria:

• HDL ≤ 0.60 mmol/L (23 mg/dl)

• Plasma LDL-Cholesterol > 155 mg/dl (4.00 mmol/L) or total cholesterol 250 mg/dl (> 6.5mmol/L) or genetic hyperlipidaemia

• Fasting triglycerides > 400 mg/dL (4.5 mmol/L)

• Known heterozygous or homozygous familial hypercholesterolaemia or know type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)

• ApoE2/E2 homozygosity, Apo E4/E4 homozygosity

• Type 2 diabetes treated with oral agents and/or insulin

• Diet treated type 2 diabetic patients with HbA1c ≥ 7%

• History of cardio vascular disease

• Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg.

• Very low-calorie diet (1200 calories a day or less) or history of surgical procedures for weight loss (e.g., stomach stapling, bypass)

• Body weight fluctuation > 5 Kg during the previous 3 months

• History of bulimia or anorexia nervosa by DSM-IV criteria

• Presence of any clinically significant endocrine disease according to the investigator, Cushing syndrome, obesity secondary to hypothalamic/pituitary disorder.

• 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.)

• Severe hepatic impairment known by the investigator or AST or ALT > 3 times the ULN at screening.

• Known severe renal dysfunction (creatinine clearance < 30 ml/min) or urine analysis (performed at screening by dipstick) showing 2+ or more protein

• 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

• Patient treated for epilepsy

• Ongoing major depressive illness

• Uncontrolled psychiatric illness

• History of alcohol and/or drug abuse

• Smoker or smoking cessation within the past 3 months

• Marijuana or hashish users

• Previous participation in a Rimonabant study or to any other clinical trial within 4 weeks to study start

• Hypersensitivity/intolerance to the active substance or to any of the excipients such as lactose

• 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

• Recent history of active peptic ulcer

• Willebrand disease or other hemorrhagic diatheses

• 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

• Anti obesity drugs

• Other drugs for weight reduction (phentermine, amphetamines)

• Herbal preparations for weight reduction

• Other drugs known to affect lipid metabolism: retinoids, antiretroviral, estrogens and hormone replacement therapy, cyclosporine, glitazones, benfluorex, fish oils, plant sterols.

• Thiazids (including fixed combination) at daily dose higher than 12.5 mg

• Unselective beta-blockers

• Prolonged use (more than one week) of systemic corticosteroids, neuroleptics

• Anticoagulants

• Ongoing antidepressive treatment

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.