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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Terminated
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
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00408148
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00408148