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High Density Lipoprotein Turnover

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00408148
Recruitment Status : Terminated (Company decision has been taken in light of recent demands by certain national health authorities)
First Posted : December 6, 2006
Last Update Posted : December 10, 2010
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Brief 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

Condition or disease Intervention/treatment Phase
Obesity Drug: Placebo Drug: Rimonabant Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Two Arm, Parallel, Placebo Controlled Study of Rimonabant 20 mg Effect on High Density Lipoprotein Kinetics in Patients With Abdominal Obesity and Additional Cardiometabolic Risk Factors
Study Start Date : October 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Placebo Comparator: 2
Administration of one rimonabant placebo tablet once daily in the morning
Drug: Placebo
Undistinguishable placebo tablets

Experimental: 1
Administration of one tablet containing 20 mg of active rimonabant once daily in the morning
Drug: Rimonabant
White film-coated, for oral administration containing 20 mg of active rimonabant

Primary Outcome Measures :
  1. The fractional catabolic rate (FCR) of HDL ApoA-I [ Time Frame: After 12 months of treatment. ]

Secondary Outcome Measures :
  1. Production Rate (PR) of HDL ApoA-I and A-II, (FCR) of HDL ApoA-II [ Time Frame: All across the study ]
  2. PR and FCR of VLDL1 and VLDL2 Apo B, VLDL1 and VLDL2 TG, IDL Apo B and LDL Apo B [ Time Frame: All across the study ]
  3. Variation in ApoA-I, ApoA-II, Lp-AI, Lp-AII, pre-beta-HDL HDL2a, HDL2b, HDL3a, HDL3b, HDL3c, Apo B, Apo C III, TG, LDL-C, HDL-C levels [ Time Frame: All across the study ]
  4. Variation in Glucose, insulin, HbA1c, leptin, adiponectin [ Time Frame: All across the study ]
  5. Variation in hs-CRP, TNF-alpha, CETP, PLTP and LCAT activities, lipoprotein and hepatic lipase activities in post-heparin plasma [ Time Frame: All across the study ]
  6. Variation in whole body fat [ Time Frame: All across the study ]
  7. Variation in abdominal sub-cutaneous and visceral fat [ Time Frame: All across the study ]
  8. Variation in liver fat [ Time Frame: All across the study ]
  9. Variation in blood pressure [ Time Frame: All across the study ]
  10. Variation in body weight, waist circumference, waist/hip ratio [ Time Frame: From the beginning to the end of the study ]
  11. CE/TG ratio in HDL [ Time Frame: All across the study ]
  12. Adverse events [ Time Frame: From the beginning to the end of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00408148

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Sanofi-Aventis Administrative Office
North Ryde, Australia
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Paris, France
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, United Kingdom
Sponsors and Collaborators
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Study Director: Valérie Pilorget Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT00408148     History of Changes
Other Study ID Numbers: RIMON_C_01346
EUDRACT # : 2006-001716-71
First Posted: December 6, 2006    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Signs and Symptoms
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs