diet-related obesity diagnosed by BMI of 30 to 45 kg/m²
Conditions
Interventions
Trade Name: ALVALIN
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: CATHINE
CAS Number: 492-39-7
Other descriptive name: D-Norpseudoephedrine
Concentration unit: mg/g milligram(s)/gram
Sponsors
Riemser Pharma GmbH
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 45 kg/m² • blood pressure after 5 min sitting at rest : =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Specific: • weight gain or loss of > 3 kg, use of a very-low-calorie diet, or participation in a formal weight loss program within the past three months • previous bariatric surgery cardiovascular diseases: e.g. o history of stroke o myocardial infarction o life-threatening arrhythmia o coronary revascularization o angina pectoris o heart failure: NYHA classification stage 3 and 4 o known clinical relevant coronary heart disease o known clinical relevant reduction of left ventricular function o serious arrhythmia o inflammatory heart disease o valvular heart disease o transient ischemic attack (TIA) o peripheral arterial disease o cerebrovascular disease • Neurologic o previous or current mental diseases, including anorexia nervosa and depression o current Hospital Anxiety and Depression Scale (HADS) score >11 o recent (previous 6 months) suicide attempt or ideation with some intent to act • history of narrow angle glaucoma • history of any cancer • untreated hypothyroidism : TSH >1.5x upper limit of normal (ULN), signs or symptoms of hypothyroidism, use of thyroid hormone treatment that was not stable for at least three months • hyperthyroidism • known history of pulmonary hypertension • diabetes type 1 • phaeochromocytoma • cushing’s syndrome or intake of glucocorticoids if the duration of the therapy surpasses the duration of an acute short term therapy • impaired kidney function: serum serum creatinine levels >1.4 mg/dL for women, >1.5 mg/dL for men • hepatic impairment: clinically significantly AST or ALT or ?-glutamyltransferase >3x ULN • insomnia • cut off limit in patients with coexisting risk factors like hyperlipidaemia and type 2 diabetes mellitus o full blood glucose (fasting) > 200 mg/dL (11.1 mmol/L) o HbA1c > 8,5 % (69,4 mmol/mol) o triglycerides > 800 mg/dL (9.14 mmol/L) o and at the discretion of the investigator • other severe systemic concomitant diseases • intake of drugs which have an impact on cathine action (see table 1 ) • known intolerance to cathine, or other ingredients of the test/reference drug • high caffeine consumption (> 6 cups / day) or intake of caffeine –containing softdrings > 1,5L • known clinically relevant coronary heart disease • known clinically relevant reduction of left ventricular function • serious arrhythmia • tendency to misuse of medication or alcohol dependency. General: • female patients only: pregnancy or lactation, insufficient contraception • suspected/confirmed drug/alcohol addiction and abuse • current or previous participation in another clinical trial within 12 weeks preceding the start of the study • legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study • unreliability or lack of cooperation and compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary endpoint is the weight reduction of at least 10% overall in the treatment group with at least 5% greater weight reduction than in the placebo group) after 52 weeks of treatment. ;Primary end point(s): Primary endpoint is the weight reduction after 52 weeks of treatment calculated as percentage of body weight lost.;Timepoint(s) of evaluation of this end point: 52 weeks;Secondary Objective: SECONDARY ENDPOINTS : • • percentage of patients with weight loss > 5 % • percentage of patients with weight loss > 10 % • weight loss in kg • serum lipids • plasma glucose, HbA1C • change in waist circumference (WC) • change in waist-hip ratio (WHR) • change in body mass index (BMI) • dose-reduction or complete withdrawal of concomitant medication for obesity-related co-morbidities • overall assessment of efficacy by physician and by patient • quality of life | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • percentage of patients with weight loss > 5 % • percentage of patients with weight loss > 10 % • weight loss in kg • serum lipids • plasma glucose, HbA1C • change in waist circumference (WC) • change in waist-hip ratio (WHR) • change in body mass index (BMI) • dose-reduction or complete withdrawal of concomitant medication for obesity-related co-morbidities • overall assessment of efficacy by physician and by patient • quality of life ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Germany
Contacts
Public ContactMedical Science & Operations
RIEMSER Pharma GmbH
Outcome results
None listed