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
Conditions
Interventions
Trade Name: Antiadipositum X 112 T
Product Name: Antiadipositum X 112 T
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Cathin-hydrochlorid
CAS Number: 2153-98-2
Other descriptive name
Sponsors
RIEMSER Arzneimittel AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary criterion is weight reduction in kilogram in the treatment groups (group 1- 3) compared with the placebo group (group 0) after 12 weeks;Secondary Objective: 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 ;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 | — |
Countries
Germany
Outcome results
None listed