E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059179 |
E.1.2 | Term | Abdominal obesity |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
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E.4 | Principal 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 . |
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E.5 End points |
E.5.1 | Primary end point(s) |
Relative change from baseline to Month 12 in visceral fat area assessed by CT scan slice L4-L5 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |