Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00408148




Registration number
NCT00408148
Ethics application status
Date submitted
5/12/2006
Date registered
6/12/2006
Date last updated
10/12/2010

Titles & IDs
Public title
High Density Lipoprotein Turnover
Scientific 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
Secondary ID [1] 0 0
EUDRACT # : 2006-001716-71
Secondary ID [2] 0 0
RIMON_C_01346
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Rimonabant

Placebo comparator: 2 - Administration of one rimonabant placebo tablet once daily in the morning

Experimental: 1 - Administration of one tablet containing 20 mg of active rimonabant once daily in the morning


Treatment: Drugs: Placebo
Undistinguishable placebo tablets

Treatment: Drugs: Rimonabant
White film-coated, for oral administration containing 20 mg of active rimonabant
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The fractional catabolic rate (FCR) of HDL ApoA-I
Timepoint [1] 0 0
After 12 months of treatment.
Secondary outcome [1] 0 0
Production Rate (PR) of HDL ApoA-I and A-II, (FCR) of HDL ApoA-II
Timepoint [1] 0 0
All across the study
Secondary outcome [2] 0 0
PR and FCR of VLDL1 and VLDL2 Apo B, VLDL1 and VLDL2 TG, IDL Apo B and LDL Apo B
Timepoint [2] 0 0
All across the study
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
All across the study
Secondary outcome [4] 0 0
Variation in Glucose, insulin, HbA1c, leptin, adiponectin
Timepoint [4] 0 0
All across the study
Secondary outcome [5] 0 0
Variation in hs-CRP, TNF-alpha, CETP, PLTP and LCAT activities, lipoprotein and hepatic lipase activities in post-heparin plasma
Timepoint [5] 0 0
All across the study
Secondary outcome [6] 0 0
Variation in whole body fat
Timepoint [6] 0 0
All across the study
Secondary outcome [7] 0 0
Variation in abdominal sub-cutaneous and visceral fat
Timepoint [7] 0 0
All across the study
Secondary outcome [8] 0 0
Variation in liver fat
Timepoint [8] 0 0
All across the study
Secondary outcome [9] 0 0
Variation in blood pressure
Timepoint [9] 0 0
All across the study
Secondary outcome [10] 0 0
Variation in body weight, waist circumference, waist/hip ratio
Timepoint [10] 0 0
From the beginning to the end of the study
Secondary outcome [11] 0 0
CE/TG ratio in HDL
Timepoint [11] 0 0
All across the study
Secondary outcome [12] 0 0
Adverse events
Timepoint [12] 0 0
From the beginning to the end of the study

Eligibility
Key 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
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Helsinki
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Guildford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Valérie Pilorget
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00408148