- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00408148
High Density Lipoprotein Turnover
December 9, 2010 updated by: Sanofi
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
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Ryde, Australia
- Sanofi-Aventis Administrative Office
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Helsinki, Finland
- Sanofi-Aventis Administrative Office
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Paris, France
- Sanofi-Aventis Administrative Office
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Guildford, United Kingdom
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 2
Administration of one rimonabant placebo tablet once daily in the morning
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Undistinguishable placebo tablets
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Experimental: 1
Administration of one tablet containing 20 mg of active rimonabant once daily in the morning
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White film-coated, for oral administration containing 20 mg of active rimonabant
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The fractional catabolic rate (FCR) of HDL ApoA-I
Time Frame: After 12 months of treatment.
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After 12 months of treatment.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Adverse events
Time Frame: From the beginning to the end of the study
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From the beginning to the end of the study
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Production Rate (PR) of HDL ApoA-I and A-II, (FCR) of HDL ApoA-II
Time Frame: All across the study
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All across the study
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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
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All across the study
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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
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All across the study
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Variation in Glucose, insulin, HbA1c, leptin, adiponectin
Time Frame: All across the study
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All across the study
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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
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All across the study
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Variation in whole body fat
Time Frame: All across the study
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All across the study
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Variation in abdominal sub-cutaneous and visceral fat
Time Frame: All across the study
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All across the study
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Variation in liver fat
Time Frame: All across the study
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All across the study
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Variation in blood pressure
Time Frame: All across the study
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All across the study
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Variation in body weight, waist circumference, waist/hip ratio
Time Frame: From the beginning to the end of the study
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From the beginning to the end of the study
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CE/TG ratio in HDL
Time Frame: All across the study
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All across the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Valérie Pilorget, Sanofi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
December 5, 2006
First Submitted That Met QC Criteria
December 5, 2006
First Posted (Estimate)
December 6, 2006
Study Record Updates
Last Update Posted (Estimate)
December 10, 2010
Last Update Submitted That Met QC Criteria
December 9, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Obesity Agents
- Cannabinoid Receptor Modulators
- Cannabinoid Receptor Antagonists
- Rimonabant
Other Study ID Numbers
- RIMON_C_01346
- EUDRACT # : 2006-001716-71
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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