EUCTR2006-002862-20-DK进行中（未招募）不适用
Effect of tesofensine on weight reduction in patients with obesity. A randomised, double-blind, placebo-controlled, parallel-group, multi-centre study. - TIPO-1
euroSearch A/S0 个研究点开始时间: 2006年7月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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
- •1. Males and females 18 to 65 years of age, extremes included
- •2. Patients continuously receiving diet therapy as well as instructions on exercise at least for 2 weeks run-in, who during the run-in before randomisation do not gain weight ( < 2 kg)
- •3. Females of childbearing potential must be non-pregnant and use safe contraceptive methods ( the pill, IUD or surgically sterilized)
- •4. Patients should be able to comply with study procedures
- •5. Smoking habits should have been stable for at least 2 months
- •6. 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Use of prescription medication
- •2. Positive serum pregnancy test for women of childbearing potential
- •3. Pregnant or lactating women, or women who are planning to become pregnant within the next 18 months
- •4. 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.
- •5. 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.
- •6. Patients currently (within the past 2 months) 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))
- •7. 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)
- •8. Known untreated hypercholesterolaemia (> 7 mmol/l). Patients with well regulated cholesterol using drugs for hypercholesterolaemia are allowed inclusion.
- •9. Known untreated hypertriglyceridaemia (> 3 mmol/l). Patients with well regulated triglyceride levels using drugs for hypertriglyceridaemia are allowed inclusion.
- •10. Drug treated thyroid diseases (well substituted long standing hypothyroidism is allowed, including hypothyroidism as a sequelae to definitive treatment of hyperthyroidism by surgery or radioactive iodine)
- •11. Special diets (e.g., vegetarian, Atkins)
- •12. Malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine
- •13. 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
- •14. Surgically treated obesity
- •15. Weight change of > 3 kg within 2 months prior to screening
- •16. Mental disorders or psychiatric disorder based on medical history only
- •17. Patients with systemic infections or inflammatory diseases
- •18. History or presence of significant cardiovascular disease such as heart failure, ischemic heart disease, stroke, transient ischemic attacks
- •19. Significant abnormalities on the ECG according to the investigators opinion. Additional exclusionary ECG values: QTcB > 480 milliseconds (ms), PR interval > 240 ms, QRS interval > 120 ms
- •20. 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
- •21. 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.
- •22. Known HIV infection (no tests required)
- •23. Serologic evidence of active hepatitis B and/or C
- •24. History of cancer within the past 5 years, excluding treated basal cell carcinoma
- •25. Clinically significant or potentially disabling eye disorder, including uncontrolled glaucoma
- •26. Current treatment with medication with known ocular toxicity
研究者
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