randomized, double blind, two-arm placebo controlled, 12-Month study of the effects of rimonabant 20 mg once daily on amount and activity of visceral fat in abdominally obese patients with metabolic syndrome. - Visceral fat reduction assessed by CT-scan On RImonabAnt

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2005-002568-27-IT
• Date of registration: 11/01/2007
• Prospective Registration: No
• Primary sponsor: SANOFI-SYNTHELABO
• Public title: randomized, double blind, two-arm placebo controlled, 12-Month study of the effects of rimonabant 20 mg once daily on amount and activity of visceral fat in abdominally obese patients with metabolic syndrome. - Visceral fat reduction assessed by CT-scan On RImonabAnt
• Scientific title: randomized, double blind, two-arm placebo controlled, 12-Month study of the effects of rimonabant 20 mg once daily on amount and activity of visceral fat in abdominally obese patients with metabolic syndrome. - Visceral fat reduction assessed by CT-scan On RImonabAnt
• Date of first enrolment: 20/03/2006
• 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 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 150 mg/dl or 1.69 mmol/L b.HDL cholesterol 50 mg/dL or 1.29 mmol/L in women or 40 mg/dL or 1.04 mmol/L in men c.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 conditiond. Fasting blood glucose 110 mg/dl or 6.1 mmol/L
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) no
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 are considered not of childbearing potential, post-menopausal women for at least 2 years or surgically sterile 3.History of very low-calorie diet or 800 kcal/day 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. Note euthyro d patient on replacement therapy can be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit 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 binge 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 studyRelated 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

Abdominal Obesity
MedDRA version: 9.1 Level: LLT Classification code 10059179 Term: Abdominal obesity

Intervention(s)

Pharmaceutical Form: Film-coated tablet
CAS Number: SR141716
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)

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

Primary end point(s): 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 ID(s)

PM-C-0172

2005-002568-27-GB