NCT00394667已完成2 期
Effect of Tesofensine on Weight Reduction in Patients With Obesity. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study.
NeuroSearch A/S2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Percent change and absolute change in body weight
研究概览
简要总结
Purpose:
To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine versus placebo in obese patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese patients with 30 kg/m² ≤ BMI ≤ 40 kg/m²
- •Males and females 18 to 65 years of age, extremes included
- •Patients continuously receiving diet therapy as well as instructions on exercise at least for 2 weeks run-in, who during the run-in before randomization do not gain weight (< 2 kg)
- •Females of childbearing potential must be non-pregnant and use safe contraceptive methods (the pill, IUD or surgically sterilized)
- •Patients should be able to comply with study procedures
- •Smoking habits should have been stable for at least 2 months
- •Patients giving written informed consent
排除标准
- •Use of prescription medication as listed
- •Positive serum pregnancy test for women of childbearing potential
- •Pregnant or lactating 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 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))
- •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
- •Weight change of > 3 kg within 2 months prior to screening
- •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), 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)
- •Serologic evidence of active hepatitis B and/or C
- •History of cancer within the past 5 years, excluding treated basal cell carcinoma
- •Clinically significant or potentially disabling eye disorder, including uncontrolled glaucoma
- •Current treatment with medication with known ocular toxicity such as chloroquine and hydroxychloroquine is prohibited
- •Patients previously treated with tesofensine
- •Patients treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study drug
结局指标
主要结局
Percent change and absolute change in body weight
次要结局
- Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA
- blood tests (Triglycerides, Cholesterol-total, LDL-C, HDL-C, LDH, Blood glucose fasting, HbA1c, C-reactive protein, Insulin and Adiponectin )
- data from questionnaires (Baecke Questionnaire, Satiety & Appetite Questionnaire, POMS, and Impact of Weight on Quality of Life Questionnaire -Lite Version (IWQOL-Lite))
- Safety & Tolerability
研究者
研究点 (2)
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