VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt (VICTORIA)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00299325
First received: March 3, 2006
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

Primary objective:

To assess the effect of rimonabant on visceral fat area over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome

Secondary objectives:

  • To assess the effect of rimonabant over a period of 12 months on:

    • Liver fat content using CT scan (Computed Tomography scan)
    • Anthropometric measures (weight, waist circumference, body composition using Dual Energy X-ray Absorptiometry (DEXA))
    • Lipid, lipoprotein profile
    • Glycemia, insulinemia and HbA1c
    • Adipokines, inflammatory and hemostatic markers
  • To evaluate the percentage of patients with metabolic syndrome at 12 months
  • To evaluate the safety and tolerability of rimonabant in these patients

In four selected US sites the effect of rimonabant at 12 months will be also assessed on:

  • Basal lipolysis and insulin suppressed lipolysis (euglycemic hyperinsulinemic clamp).
  • Resting metabolic rate and substrate oxidation at rest using indirect calorimetry.
  • Adipose tissue histology and expression of genes involved in glucose and lipid metabolism (superficial adipose tissue biopsy).

Condition Intervention Phase
Metabolic Syndrome
Drug: Rimonabant
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Two-arm Placebo Controlled, 12-Month Study of the Effects of Rimonabant 20mg Once Daily on the Amount and the Activity of Visceral Fat in Abdominally Obese Patients With Metabolic Syndrome.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Relative change in visceral fat area assessed by CT scan [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change in visceral fat area assessed by CT scan [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
  • Relative and absolute changes in: Liver fat content measured using CT scan, Anthropometric measures, Specific lipid parameters, Glucose control parameters, Adipokines, inflammatory and hemostatic markers [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
  • Percentages of patients with a metabolic syndrome [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]
  • Standard laboratory blood test [ Time Frame: At baseline, 3 months, 7 months and 12 months ] [ Designated as safety issue: No ]

Enrollment: 254
Study Start Date: March 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Once daily in the morning
Drug: Rimonabant
White-opaque tablets, for oral administration containing 20 mg of active rimonabant
Placebo Comparator: 2
Once daily in the morning
Drug: Placebo
Undistinguishable placebo tablets

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Waist circumference > 102 cm in men and > 88 cm in women
  • Two other components of the metabolic syndrome (NCEP/ATPIII definition) among the following :

    • Triglyceridemia ≥ 150 mg/dl (or 1.69 mmol/L)
    • HDL cholesterol < 50 mg/dL (or 1.29 mmol/L) in women or < 40 mg/dL (or 1.04 mmol/L) in men
    • Blood pressure ≥ 130/85 mmHg (systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg) or Treatment with antihypertensive agent(s) for this condition
    • Fasting blood glucose > 110 mg/dl (or 6.1 mmol/L)

Exclusion criteria :

  • Positive pregnancy test, pregnant or breast-feeding women, or women planning to become pregnant or breastfeed
  • Absence of medically approved contraceptive methods for female of childbearing potential
  • History of very low-calorie diet (≤ 800 kcal/day) within 3 months prior to screening visit
  • History of surgical procedures for weight loss (eg, stomach stapling, bypass).
  • Presence of any clinically significant endocrine disease according to the investigator.
  • Weight change > 5 kg within 3 months prior to screening visit
  • Obese patients (BMI> 40 kg/m²)
  • Established type 1 or 2 diabetes (treated or untreated): at least 2 measures of fasting blood glucose ≥ 126 mg/dl
  • Severe renal dysfunction (creatinine clearance < 30 ml/min) or nephrotic syndrome
  • Chronic hepatitis or clinically significant hepatic disease
  • Positive test for hepatitis B or C
  • Marijuana or hashish users
  • Significant haematology abnormalities (haemoglobin < 100 g/L and/or neutrophils < 1.5 G/L and/or platelets < 100 G/L).
  • Presence or history of cancer within the past 5 years with the exception of adequately treated basal cell skin cancer or in situ uterine cervical cancer
  • Presence or history of severe depression that can be defined as depression which necessitated the patient to be hospitalised, or patient with 2 or more recurrent episodes of depression or an history of suicide attempt
  • Presence or history of bulimia or anorexia nervosa (DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria) or binge eating disorders
  • Presence of any other condition (eg geographical, social…) current or anticipated that the Investigator feels that would restrict or limit the subject's participation for the duration of the studyRelated to previous or concomitant drugs that could interfere with the evaluation of study drug effects
  • Administration of any investigational treatment (drug or device) within 30 days prior to screening
  • Previous participation in a rimonabant study
  • Administration of any of the following within 3 months prior to screening visit:

    • anti obesity drugs (eg, sibutramine, orlistat)
    • other drugs for weight reduction (phentermine, amphetamines)
    • herbal preparations for weight reduction
    • thyroid preparations or thyroxin treatment (except in patients on replacement therapy on a stable dose)
  • Patient treated within the last 3 months with nicotinic acid, fibrates, bile acid sequestrants or ezetimibe (patients treated with statins can be included if the dose received is stable since at least 3 months and should not be modified during the whole study period).
  • Patient treated with antidiabetic drug(s).
  • Prolonged use (more than one week) within the last 3 months of systemic corticosteroids, neuroleptics, or antidepressants (including bupropion).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299325

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Denmark
Sanofi-Aventis Administrative Office
Hoersholm, Denmark
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-Aventis Administrative Office
Stockholm, Sweden
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Valérie Pilorget, MD Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00299325     History of Changes
Other Study ID Numbers: PM_C_0172, EUDRACT # : 2005-002568-27
Study First Received: March 3, 2006
Last Updated: December 9, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014