High Density Lipoprotein Turnover

NCT ID: NCT00408148

Last Updated: 2010-12-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-12-31

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

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2

Administration of one rimonabant placebo tablet once daily in the morning

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Undistinguishable placebo tablets

1

Administration of one tablet containing 20 mg of active rimonabant once daily in the morning

Group Type: EXPERIMENTAL

Rimonabant

Intervention Type: DRUG

White film-coated, for oral administration containing 20 mg of active rimonabant

Interventions

Placebo

Undistinguishable placebo tablets

Intervention Type: DRUG

Rimonabant

White film-coated, for oral administration containing 20 mg of active rimonabant

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Valérie Pilorget

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

North Ryde, , Australia

Sanofi-Aventis Administrative Office

Helsinki, , Finland

Sanofi-Aventis Administrative Office

Paris, , France

Sanofi-Aventis Administrative Office

Guildford, , United Kingdom

Countries

Australia; Finland; France; United Kingdom

References

Verges B, Adiels M, Boren J, Barrett PH, Watts GF, Chan D, Duvillard L, Soderlund S, Matikainen N, Kahri J, Robin I, Taskinen MR. Interrelationships between the kinetics of VLDL subspecies and HDL catabolism in abdominal obesity: a multicenter tracer kinetic study. J Clin Endocrinol Metab. 2014 Nov;99(11):4281-90. doi: 10.1210/jc.2014-2365. Epub 2014 Jul 31.

Reference Type: DERIVED

PMID: 25077901 (View on PubMed)

Other Identifiers

EUDRACT # : 2006-001716-71

Identifier Type: -

Identifier Source: secondary_id

RIMON_C_01346

Identifier Type: -

Identifier Source: org_study_id