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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rimonabant
Placebo (for Rimonabant)
Mild hypocaloric diet
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rimonabant

Placebo

Arm Description

Rimonabant 20 mg once daily with mild hypocaloric diet

Placebo (for Rimonabant) once daily with mild hypocaloric diet

Outcomes

Primary Outcome Measures

Relative change in visceral fat area assessed by CT scan

Secondary Outcome Measures

Absolute change in visceral fat area assessed by CT scan
Change in Liver fat content measured using CT scan
Change in anthropometric measures
Change in specific lipid parameters
Change in glucose control parameters
Change in adipokines, inflammatory and hemostatic markers
Percentages of patients with a metabolic syndrome

Full Information

First Posted
March 3, 2006
Last Updated
June 1, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00299325
Brief Title
VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt
Acronym
VICTORIA
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rimonabant
Arm Type
Experimental
Arm Description
Rimonabant 20 mg once daily with mild hypocaloric diet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for Rimonabant) once daily with mild hypocaloric diet
Intervention Type
Drug
Intervention Name(s)
Rimonabant
Other Intervention Name(s)
SR141716, Acomplia
Intervention Description
Tablet, oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo (for Rimonabant)
Intervention Description
Tablet, oral administration
Intervention Type
Other
Intervention Name(s)
Mild hypocaloric diet
Intervention Description
Calculated by the dietitian based on the estimated basal metabolism rate and the physical activity
Primary Outcome Measure Information:
Title
Relative change in visceral fat area assessed by CT scan
Time Frame
From baseline to Month 12
Secondary Outcome Measure Information:
Title
Absolute change in visceral fat area assessed by CT scan
Time Frame
From baseline to Month 12
Title
Change in Liver fat content measured using CT scan
Time Frame
From baseline to Month 12
Title
Change in anthropometric measures
Time Frame
From baseline to Month 12
Title
Change in specific lipid parameters
Time Frame
From baseline to Month 12
Title
Change in glucose control parameters
Time Frame
From baseline to Month 12
Title
Change in adipokines, inflammatory and hemostatic markers
Time Frame
From baseline to Month 12
Title
Percentages of patients with a metabolic syndrome
Time Frame
At 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Pilorget, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Hoersholm
Country
Denmark
Facility Name
Sanofi-Aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Milan
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Stockholm
Country
Sweden
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22170727
Citation
Triay J, Mundi M, Klein S, Toledo FG, Smith SR, Abu-Lebdeh H, Jensen M. Does rimonabant independently affect free fatty acid and glucose metabolism? J Clin Endocrinol Metab. 2012 Mar;97(3):819-27. doi: 10.1210/jc.2011-2486. Epub 2011 Dec 14.
Results Reference
result

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VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt

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