E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adiposity is another risk factor for developing cardiac insufficiency and myocardial hypertrophy. Probably the volume loading of the left ventricle, systemic inflammation, the fatty degeneration of the heart, and mycardial insulin resistance are involved in the pathogenesis of adiposity-associated heart insufficiency. Because Rimonabant reduces the body weight and improves the above-named symptoms it may prevent heart insufficiency and cardiac arrhythmia in adipose patients.
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MedDRA Classification |
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 |
Absolute change of the mass of the left ventricle after 36 weeks treatment with Rimonabant compared with placebo |
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E.2.2 | Secondary objectives of the trial |
- absolute and relative changes of the mass of the left ventricle within the two study groups - changes in the diameter and volume of the left ventricle - changes in the function, in the cardiac output per minute, in the systolic stress, and the systemic vascular resistance -changes in the amount of pericardial fatty tissue compared to the abdominal and intra hepatic fatty tissue |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• abdominal adiposity (waist circumference >102 cm men, >88 cm women) • blood pressure <140/90 mm Hg • age 18-60 years • possibility to discontinue concomitant medication during treatment with the study drug • women of childbearing potential with adequate contraception |
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E.4 | Principal exclusion criteria |
• body mass index <28 or >40 kg/m2 • weight >130kg • increase in body weight >2 kg in the run-in phase • changes in body weight >2 kg within 3 month prior to study start; history of surgical reduction of body weight • Diabetes mellitus Type 1 or 2 • familiar alterations of metabolism • hepatic disease, Cholestase (transaminases or gamma-GT increased more than 2- fold) • symptomatic or detected coronary heart disease, myocardial infarct • heart insufficiency NYHA II-IV • symptomatic/detected valvular defect • symptomatic or detected peripheral arterial occlusive disease • atherosclerosis der hirnversorgenden Arterien, TIA or apoplexia • renal insufficiency or serum creatinine above the normal range • sleep apnoea • coagulation disorder or intake of oral anticoagulants • contraindication to do cardiac MRTs: pacemaker or other metal implantations, atrial fibrillation • disease or operation effecting drug resorption • pregnancy or breastfeeding • autoimmune disease; organ transplantation; History of malignancy and chronic diseases • history of alcohol or drug abuse, or both; psychiatric disorder • history of treated or untreated depressive phases • intake of antidepressants or drugs to reduce the body weight during the last year prior to study start • Participation in another investigational drug trial within the eight weeks prior to study entry • incompatibility to Rimonabant or ingredients of the study drug • incompatibility to Lidocain • patients with epilepsy or anamnestischen Krampfanfällen • patients with hereditary galactose intolerance, lactase deficiency or glucose- galactose malabsorption
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E.5 End points |
E.5.1 | Primary end point(s) |
Absolute change of the mass of the left ventricle after 36 weeks treatment with Rimonabant compared with placebo |
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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 | No |
E.6.5 | Efficacy | No |
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.8.5 | 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 | 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 | 6 |
E.8.9.1 | In the Member State concerned days | |