DRKS00005184招募中3 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 - CTU 079G
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 530
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •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 : <160/<90 mmHg
- •resting pulse rate after 5 min sitting at rest: <90 min-1
- •written informed consent given by patient after being provided with detailed information about the aims, nature, and risks of the clinical trial as well as the expected treatment effects and potential adverse reactions associated with the drug
- •female subjects of childbearing potential willing to use contraception during the study period or with secondary infertility. A highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs (intrauterine device), sexual abstinence or vasectomised partner. Female subjects of non childbearing potential, i.e. having had hysterectomy, bilateral ovariectomy or tubal ligation or women who are post-menopausal defined as absence of menstrual bleeding for 1 year, or 6 month if laboratory confirmation of hormonal status can be included
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
- •phaeochromocytoma
- •history of narrow angle glaucoma
- •history of any cancer
- •untreated hypothyroidism : TSH >1.5 x 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
- •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 creatinine levels >1.4 mg/dL for women, >1.5 mg/dL for men
- •hepatic impairment: clinically significantl AST or ALT or gamma-glutamyltransferase >3 x ULN
- •cut off limit in patients with coexisting risk factors like hyperlipidaemia and type 2 diabetes mellitus
- •o fasting plasma glucose > 200 mg/dL (11.1 mmol/L)
- •o HbA1c > 8,5 % (69,4 mmol/mol)
- •o triglycerides > 800 mg/dL (9.14 mmol/L)
- •other severe systemic concomitant diseases
- •intake of drugs which have an impact on cathine action, tendency to misuse of medication or alcohol dependency
- •known intolerance to cathine or other ingredients of the test/reference drug
- •high caffeine consumption (> 6 cups / day) or intake of caffeine –containing soft drinks > 1,5L
- •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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