E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
abdominally obese patients with dyslipidemia |
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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 | SOC |
E.1.2 | Classification code | 10027433 |
E.1.2 | Term | Metabolism and nutrition disorders |
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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 20 mg on changes in, HDL-Cholesterol HDL-C , triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other 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 and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients. In selected sites, a sub study will be conducted to determine the effect of 12 months of Rimonabant on additional lipoprotein and inflammatory parameters. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
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 27 kg/m and 40 kg/m , 4 Willingness and ability to comply with the study protocol, 5 Waist Circumference 88 cm in women; 102 cm in men, 6 HDL cholesterol 40 mg/dL 1.03 mmol/L for men; 50 mg/dL 1.29 mmol/L for women, 7 Triglycerides 8804; 400 mg/dL 4.52 mmol/L and 8805; 150 mg/dL 1.69 mmol/L , 8 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, |
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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 euthyro d status , 8 Established type 1 or 2 diabetes treated, or with at least 2 measures of fasting blood glucose 8805; 126 mg/dl, 9 Triglyceride level 400 mg/dL 4.52 mmol/L , 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 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, |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline to month 12 in 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 | 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 | No |
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 | Yes |
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 | 6 |
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 | 0 |