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 | PT |
E.1.2 | Classification code | 10033307 |
E.1.2 | Term | Overweight |
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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 compare the efficacy of either Rimonabant or placebo therapy as an adjunct to hypocaloric diet and lifestyle intervention in subjects with the metabolic syndrome. |
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E.2.2 | Secondary objectives of the trial |
To compare the change in visceral adipose tissue mass To evaluate the change in total body fat To evaluate the change in fat deposition at the extremities To evaluate the effect of treatment on extramyocellular and intramyocellular lipids of the soleus and tibialis anterior muscles To explore the effect of treatment on insulin sensivity To evaluate the impact of treatment on serum lipids and lipoproteins To explore the impact of treatment on serum markers of inflammation To explore the impact of treatment on intima-media thickness of the common carotid artery To explore the impact of treatment on flow-mediated dilation of the brachial artery To explore the impact of treatment on prevascular fat of the brachial artery To explore the impact of treatment on body fat and body weight To explore the impact of treatment on eating patterns
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age: 18 - 70 years, inclusive Gender: male, female BMI: 27- 45 Metabolic syndrome according to the ATP III criteria (any 3 of the following): Abdominal obesity: waist circumference > 102 cm (men), > 88 cm (women) Triglyzeride 150 mg/dl HDL < 40 mg/dl (men), < 50 mg/dl (women) Blood pressure 130/ 85 mmHg Fasting glucose 110 mg/dl Or impaired fasting glucose 5.6 mmol/l and 7.0 mmol/l Or impaired glucose tolerance : 2-h-glucose (75g OGTT) 7.8 mmol/l and 11.1 mmol/l Stable weight (+ 5 kg) in the last 6 months No lifestyle intervention study in the last 6 months Willing and able to complete screening and study procedures, as described in the protocol Signed written informed consent to participate in the study
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E.4 | Principal exclusion criteria |
General health problems (e.g. cancer, cardiovascular events in the past 12 months) Significant findings indicating: cardiovascular, endocrine, pulmonary, neurologic, psychiatric, gastrointestinal, hepatic, hematologic, renal, or dermatologic disease Any of the following blood examination results: Positive hepatitis-B-surface-antigen Positive hepatitis-C antibody Positive HIV-antibodies Abnormal thyrotropin level GPT, GOT > 2.5 times the upper limit of the normal range Haemoglobin levels < 11 g/dl Neutrophil levels < 1500 /mm3 Platelet levels < 100.000/ mm3 Creatinine level > 150 mol/l Any positive history of marijuana or hashish use, no matter how long ago or a positive drug test for marijuana or hashish Acutal misuse of other drugs Severe depression (requiring hospitalization or indicated by a suicidal attempt) Mild or severe depression according to the depression questionnaire (MDI) at screening Antidepressive pharmacological treatment Treatment for epilepsy and eating disorder or a malignant disease Diabetes mellitus (type 1 or 2) Pharmacological treatment of dyslipidemia within 6 weeks before screening Pregnancy Lactation Systolic blood pressure > 165 mmHg Diastolic blood pressure > 105 mmHg Hypersensivity to the active substance or to any of the exipients (see SPC appendix 17.1) Exclusion criterias for MRT-, 1HMRS- examinations: non-compliance, pace maker, cochlea implant, nerve stimulators, magnetic vascular clips, metallic heart valve or other contraindications for MRT-, 1HMRS- examinations Patients with lactose intolerance, rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose Regular use potent CYP3A4 inhibitiors: ketoconazole, itraconazole, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir (protease inhibitors), delavirdin, erythromycin, telithromycin, clarithromycin, nefazodone, cimetidine, fluoxetine, fluvoxamine, paroxetine, sertaline, naringenine (grape fruit juice), verapamile Potent CYPA3-Inducers: rifampicin, phenytoin, phenobarbital, carbamazepine, St John’s wort Any Medication containing cannabis |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the change in liver fat content |
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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 | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 0 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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 | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |