NCT00299325|CompletedPhase 3DMC

VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt

VICTORIA

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.

Sanofi ClinicalTrials.gov

Compare

2 other identifiers

PM_C_01722005-002568-27

Study Type

interventional

Target

254

Locations

9 countries

Sites

Timeline

RegisteredMar 2006

StartedFeb 2006

CompletionJul 2008

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

254

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Feb 2006

Geographic Reach

9 countries

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

Study Start

First participant enrolled

February 1, 2006

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2006

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed

Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

2.4 years

First QC Date

March 3, 2006

Last Update Submit

June 1, 2016

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

Relative change in visceral fat area assessed by CT scan
From baseline to Month 12

Secondary Outcomes (7)

Absolute change in visceral fat area assessed by CT scan
From baseline to Month 12
Change in Liver fat content measured using CT scan
From baseline to Month 12
Change in anthropometric measures
From baseline to Month 12
Change in specific lipid parameters
From baseline to Month 12
Change in glucose control parameters
From baseline to Month 12
+2 more secondary outcomes

Study Arms (2)

Rimonabant

EXPERIMENTAL

Rimonabant 20 mg once daily with mild hypocaloric diet

Drug: RimonabantOther: Mild hypocaloric diet

Placebo

PLACEBO COMPARATOR

Placebo (for Rimonabant) once daily with mild hypocaloric diet

Drug: Placebo (for Rimonabant)Other: Mild hypocaloric diet

Interventions

RimonabantDRUG

Tablet, oral administration

Also known as: SR141716, Acomplia

Rimonabant

Placebo (for Rimonabant)DRUG

Tablet, oral administration

Placebo

Mild hypocaloric dietOTHER

Calculated by the dietitian based on the estimated basal metabolism rate and the physical activity

PlaceboRimonabant

Eligibility Criteria

Age35 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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
+13 more criteria

Contact the study team to confirm eligibility.