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. - VICTORIA

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2005-002568-27-DK
• Date of registration: 21/12/2005
• Prospective Registration: Yes
• Primary sponsor: Sanofi-Aventis Groupe
• Public 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. - VICTORIA
• Scientific 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. - VICTORIA
• Date of first enrolment: 23/01/2006
• Target sample size: 232
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002568-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Denmark, Italy, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female patients aged >or=35 years and < 70 years old.
2. Waist circumference > 102 cm in men and > 88 cm in women
3. Two other components of the metabolic syndrome (NCEP/ATPIII definition) among the following :

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

4. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Related to general subjects characteristics / concomitant diseases:

1. Positive pregnancy test, pregnant or breast-feeding women, or women planning to become pregnant or breastfeed
2. Absence of medically approved contraceptive methods for female of childbearing potential
3. History of very low-calorie diet within 3 months prior to screening visit
4. History of surgical procedures for weight loss (eg, stomach stapling, bypass).
5. Presence of any clinically significant endocrine disease according to the investigator.
6. Weight change > 5 kg within 3 months prior to screening visit
7. Morbid obese patients (BMI > 40 kg/m2)
8. Established type 1 or 2 diabetes (treated or untreated): at least 2 measures of fasting blood glucose > 126 mg/dl
9. Severe renal dysfunction (creatinine clearance < 30 ml/min) or nephrotic syndrome
10. Chronic hepatitis or clinically significant hepatic disease
11. Positive test for hepatitis B or C
12. Marijuana or hashish users
13. Significant haematology abnormalities (haemoglobin < 100 g/L and/or neutrophils < 1.5 G/L and/or platelets < 100 G/L).
14. Inability to follow verbal and written instructions
15. Presence of any severe medical or psychological condition, that in the opinion of the Investigator would compromise the subject’s safety compliance to the protocol or successful participation in the study
16. 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
17. 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
18. Presence or history of bulimia or anorexia nervosa (DSM-IV criteria) or bing eating disorders
19. 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 study

Related to previous or concomitant drugs that could interfere with the evaluation of study drug effects:

20. Administration of any investigational treatment (drug or device) within 30 days prior to screening
21. Previous participation in a rimonabant study
22. 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)
23. 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).
24. Patient treated with antidiabetic drug(s).
25. Prolonged use (more than one week) within the last 3 months of systemic corticosteroids, neuroleptics, or antidepressants (including bupropion).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Abdominally obese patients with metabolic syndrome
MedDRA version: 8.0 Level: LLT Classification code 10029883

Intervention(s)

Product Name: Rimonabant
Product Code: SR141716
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rimonabant
CAS Number: 168273-06-1
Current Sponsor code: SR141716
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Primary criterion: Relative change from baseline to Month 12 in visceral fat area assessed by CT scan (slice L4-L5)

Main 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 Objective: To assess the effect of rimonabant over a period of 12 months on:
- Liver fat content using CT 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.

Secondary ID(s)

PM-C-0172

2005-002568-27-GB

NCT00299325