E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
abdominaly obese patients with impaired fasting blood glucose and with or without associated comorbidities |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities. |
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E.2.2 | Secondary objectives of the trial |
To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic parameters and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Informed consent must be obtained in writing for all subjects at enrollment into the study, 2) Male or female 18-75 years of age, 3) BMI >30Kg/m2, or >27kg/m2 if associated with risk factor(s) such as dyslipidemia, and < 40kg/m2, 4) Willingness and ability to comply with the study protocol, 5) Waist Circumference > 88 cm in women; > 102 cm in men, 6) Confirmed (by at least 2 measurements) impaired Fasting Plasma Glucose (FPG ≥ 100 mg/dl (5.6 mmol/L) and < 126 mg/dl (7.0 mmol/L) in non diabetic patients, 7) LDL cholesterol < 130 mg/dl (3.36 mmol/L) including patients on a stable dose of statin therapy for at least 8 weeks prior to screening,
Concomitant medications: 8) Current treatment with statins and/or antihypertensive therapy must be at fixed and stable dose for at least 8 weeks prior to screening visit, 9) Patients, who are willing and in the opinion of the Investigator safely able to remain on stable and fixed doses of antihypertensive, and statins without adding additional medications or changing current treatment for the duration of the trial.
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E.4 | Principal exclusion criteria |
1) Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed (excluded by pregnancy test), 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 (lower than 1200 Kcal/day), 4) Weight change > 5 kg within 3 months prior to screening visit, 5) History of surgical procedures for weight loss (e.g., stomach stapling, bypass), 6) History of bulimia or anorexia nervosa as per DSM-IV criteria (see appendix A), 7) Presence of any clinically significant endocrine disease according to the investigator, in particular known abnormal TSH and free T4 blood level (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status), 8) Established type 1 or 2 diabetes treated, or with at least 2 measures of fasting blood glucose ≥ 126 mg/dl /L, 9) Triglyceride level > 400 mg/dL (4.52 mmol), 10) Systolic blood pressure > 160 mm Hg or diastolic blood pressure >100 mmHg at screening visit, 11) Known severe renal dysfunction (creatinine clearance < 30 ml/min) or nephrotic syndrome or urinalysis (performed at screening by dipstick) showing 2+ or more protein, 12) Known severe hepatic impairment or AST and/or ALT > 3 times the upper limit of normal at screening, 13) Presence of any condition (medical, including clinically significant abnormal laboratory tests, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient’s safety or limit his/her successful participation to the study. In particular : • Cardiac abnormalities: cardiac failure status NYHA III or IV, relevant acute abnormal finding seen on ECG at screening or within 6 months before screening, • Any current malignancy or any cancer within the past five years (except adequately treated basal cell skin cancer or cervix carcinoma in situ), • Significant haematology abnormalities (haemoglobin < 100 g/L and/or neutrophils < 1.5 G/L and/or platelets < 100 G/L), • Acute psychiatric disorders, mental condition or clinical relevant history of epilepsy which could interfere with the patient’s compliance or safe participation in the study, 14) Uncontrolled serious psychiatric illness such as a major depression, 15) History of alcohol or other substance abuse, 16) Hypersensitivity /intolerance to the active substance or to any of the excipients such as lactose,
Concomitant medications prior to study entry: 17) Administration of any investigational treatment (drug or device) within 30 days prior to screening, 18) Previous participation in a Rimonabant study, 19) Administration of any of the following within 3 months prior to screening visit: a. Anti obesity drugs (eg, sibutramine, orlistat), b. Other drugs for weight reduction (phentermine, amphetamines), c. Herbal preparations for weight reduction, d. Nicotinic acid, fibrates or bile acid sequestrants , e. Prolonged use (more than one week) of systemic corticosteroids, neuroleptics. 20) Current use of antidepressants (including bupropion
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint : Mean change from baseline to month 12 in the co-primary endpoint : FPG, HDL-C and triglyceride levels.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 423 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |