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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00299325
Recruitment Status : Completed
First Posted : March 6, 2006
Last Update Posted : June 6, 2016
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Rimonabant Drug: Placebo (for Rimonabant) Other: Mild hypocaloric diet Phase 3

Detailed Description:
The total duration per patient will be approximately 15 months including a 12-month double-blind treatment period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : February 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rimonabant
Rimonabant 20 mg once daily with mild hypocaloric diet
Drug: Rimonabant
Tablet, oral administration
Other Names:
  • SR141716
  • Acomplia

Other: Mild hypocaloric diet
Calculated by the dietitian based on the estimated basal metabolism rate and the physical activity

Placebo Comparator: Placebo
Placebo (for Rimonabant) once daily with mild hypocaloric diet
Drug: Placebo (for Rimonabant)
Tablet, oral administration

Other: Mild hypocaloric diet
Calculated by the dietitian based on the estimated basal metabolism rate and the physical activity

Primary Outcome Measures :
  1. Relative change in visceral fat area assessed by CT scan [ Time Frame: From baseline to Month 12 ]

Secondary Outcome Measures :
  1. Absolute change in visceral fat area assessed by CT scan [ Time Frame: From baseline to Month 12 ]
  2. Change in Liver fat content measured using CT scan [ Time Frame: From baseline to Month 12 ]
  3. Change in anthropometric measures [ Time Frame: From baseline to Month 12 ]
  4. Change in specific lipid parameters [ Time Frame: From baseline to Month 12 ]
  5. Change in glucose control parameters [ Time Frame: From baseline to Month 12 ]
  6. Change in adipokines, inflammatory and hemostatic markers [ Time Frame: From baseline to Month 12 ]
  7. Percentages of patients with a metabolic syndrome [ Time Frame: At 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299325

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Hoersholm, Denmark
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Milan, Italy
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Stockholm, Sweden
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, United Kingdom
Sponsors and Collaborators
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Study Director: Valérie Pilorget, MD Sanofi
Publications of Results:
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00299325    
Other Study ID Numbers: PM_C_0172
2005-002568-27 ( EudraCT Number )
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs