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High Density Lipoprotein Turnover

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Sanofi

Status and phase

Terminated
Phase 3

Conditions

Obesity

Treatments

Drug: Rimonabant
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00408148
EUDRACT # : 2006-001716-71
RIMON_C_01346

Details and patient eligibility

About

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

Enrollment

64 patients

Sex

All

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 2 patient groups, including a placebo group

2
Placebo Comparator group
Description:
Administration of one rimonabant placebo tablet once daily in the morning
Treatment:
Drug: Placebo
1
Experimental group
Description:
Administration of one tablet containing 20 mg of active rimonabant once daily in the morning
Treatment:
Drug: Rimonabant

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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