E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
diet-related obesity diagnosed by BMI of 30 to 40 kg/m² or diet-related obesity diagnosed by BMI of 27 to 40 kg/m² in patient with coexisting risk factors like hyperlipidaemia, type 2 diabetes mellitus |
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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 |
Primary criterion is weight reduction in kilogram in the treatment groups (group 1- 3) compared with the placebo group (group 0) after 12 weeks |
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E.2.2 | Secondary objectives of the trial |
1. evaluation of tachyphylaxia within the first 12 weeks, and, in case of the consent for a prolongation of the trial under well defined circumstances, within the 24 weeks period of treatment. 2. blood pressure effects 3. pulse effects 4. percentage of patients with weight loss > 5 % 5. percentage of patients with weight loss > 10 % 6. serum lipids 7. serum glucose 8. change of waist circumference (WC) 9. change of waist-hip ratio (WHR) 10. change of body Mass Index (BMI) 11. weight reduction in the period of 24 weeks (in case of the consent for a prolongation of the trial under well defined circumstances
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• male and female patients, aged 18-65 years • caucasian origin • diet-related obesity diagnosed by BMI of 30 to 40 kg/m² or diet-related obesity diagnosed by BMI of 27 to 40 kg/m² in patient with coexisting risk factors like hyperlipidaemia, type 2 diabetes mellitus
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E.4 | Principal exclusion criteria |
• organic reasons for obesity, e.g. hypothyroidism • severe eating disorder • clinically significant cardiac, neuropsychiatric or endocrine disorder • Gilles-de-la-Tourette-Syndrom • unstable coronary heart disease, heart insufficiency, tachycardia, peripheral artery occlusive disease, hearth rhythm disturbances, angina pectoris, cerebrovascular diseases • severe arterial and pulmonary hypertension • Cushing’s syndrome • impaired liver function • impaired kidney function • men: prostate hypertrophy • phaeochromocytoma • diseases which lead to an increase in intraocular pressure • epilepsy • haemorrhagic diathesis • other severe systemic concomitant diseases (except type 2 diabetes mellitus, hyperlipidaemia) • intake of drugs which increase blood pressure and heart rate e.g drugs against cough, cold and allergies like ephedrine and pseudoephedrine and drugs with a decongestant effect like xylometazoline. • application of adrenergic amines, concurrent or less than two weeks back application of monoaminooxidase inhibitor (MAO-inhibitor), amantadine as well as central nervous system effective drugs for the treatment of mental diseases (e.g. antidepressants, neuroleptics) or drugs for weight reduction or tryptophane for the treatment of insomnia • intake of guanethidine. • intake of neuroleptics like phenothiazine and butyrophenone. • known intolerance to Cahine , or other ingredients of the test/reference drug • high caffeine consumption (6 and more cups coffee/day)
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary criterion is weight reduction in kilogram in the treatment groups (group 1- 3) compared with the placebo group (group 0) after 12 weeks |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | 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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Last visit of last patient |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |