EUCTR2012-003426-24-DE进行中（未招募）1 期
A multicentre double blind placebo controlled clinical trial to assess efficacy and safety of Alvalin® (cathine hydrochloride) vs. placebo in 265 obese patients/group with a body mass index (BMI) between 30 and 45 kg/m2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 : <160/<90 mmHg
- •resting pulse rate after 5 min sitting at rest: <90 min-1
- •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 530
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
- •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.
- •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
研究者
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