EUCTR2007-001121-10-DK进行中（未招募）1 期
Evaluation of long term safety of tesofensine in patients with obesety. - TIPO-1 Extension
euroSearch A/S0 个研究点开始时间: 2007年4月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Males and females 18 to 65,5 years of age, extremes included
- •Patients continuously receiving diet therapy as well as instructions on exercise
- •Females of childbearing potential must be non-pregnant and use safe contraceptive methods (the pill, IUD, injection of prolonged gestagen, sub dermal implantation, hormonal vaginal devices, transdermal patches or surgically sterilized)
- •Patients should be able to comply with study procedures
- •Patients giving written informed consent
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with a BMI< 22
- •Use of prescription medication as listed in Appendix 1
- •Positive pregnancy test for women of childbearing potential
- •Pregnant women, or women who are planning to become pregnant within the next 8 months
- •Patients with specific diseases interfering with their metabolism e.g. untreated myxoedema, Cushing’s syndrome, Type 1 diabetes mellitus, significant neurological or psychiatric illness such as epilepsy, schizophrenia, depression, eating disorders such as bulimia.
- •Patients with Type 2 diabetes mellitus are ineligible unless anti-diabetic medication was not deemed necessary by the investigator and fasting (venous or arterialized capillary full blood from finger or ear) blood glucose > 6.1 mmol/l at screening. Re-test is allowed if first measure is above inclusion value. The corresponding exclusion criteria for plasma glucose is 7.0 mmol/l
- •Patients known to abuse or to be dependent on any drug, including alcohol (weekly consumption > 21 units of alcohol (men) or >14 units of alcohol (women))
- •Hepatic or renal dysfunction (ASAT and/or ALAT > 2 x ULN and creatinine clearance < 30 mL/min estimated by central laboratory using Cockcroft and Gault formula, respectively)
- •Known untreated hypercholesterolaemia (> 7 mmol/l). Patients with well regulated cholesterol using drugs for hypercholesterolaemia are allowed inclusion
- •Known untreated hypertriglyceridaemia (> 3 mmol/l). Patients with well regulated triglyceride levels using drugs for hypertriglyceridaemia are allowed inclusion
- •Drug treated thyroid diseases (well substituted hypothyroidism is allowed)
- •Patients who suffer from hyperthyroid disease are not allowed in the study, even though they may be well treated by drugs
- •Patients, who have recently diagnosed, not yet stable hypothyroid disease are not allowed in the study
- •Patients who suffer from longstanding stable hypothyroid disease, well treated substitution are allowed to be included including hypothyroidism as a sequelae to definitive treatment of hyperthyroidism by surgery or radioactive iodine
- •Malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine
- •Special diets (e.g., vegetarian, Atkins)
- •Patients planning major changes in physical activity during the study to an extent that may interfere with the study outcome, as judged by the investigator
- •Mental or psychiatric disorder based on medical history only
- •Surgically treated obesity
- •Patients with systemic infections or inflammatory diseases
- •History or presence of significant cardiovascular disease such as heart failure, ischemic heart disease, stroke, transient ischemic attacks
- •Significant abnormalities on the ECG. according to the investigators opinion. Additional exclusionary ECG values: QTcB > 480 milliseconds (ms) in females and >450 ms in males, PR interval > 240 ms, QRS interval > 120 ms
- •Hypotension (i.e. supine systolic BP < 90 mm Hg) and/or symptomatic orthostatic hypotension (clinical symptoms of orthostatic hypotension associated with a decline = 20 mm Hg in systolic BP at one minute after standing compared with the previous supine systolic BP obtained after 5 minutes of quiet rest) at screening visit
- •Uncontrolled hypertension (i.e. sitting diastolic BP = 95 mm Hg and sitting systolic BP = 155 mm Hg) despite treatment for > 4 weeks prior to the screening visit as well as HR>90 bpm
- •Known HIV infection (no tests required)
- •History of cancer within the past 5 years, excluding treated basal cell carc
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