EUCTR2005-002568-27-IT进行中（未招募）不适用
randomized, double blind, two-arm placebo controlled, 12-Month study of the effects of rimonabant 20 mg once daily on amount and activity of visceral fat in abdominally obese patients with metabolic syndrome. - Visceral fat reduction assessed by CT-scan On RImonabAnt
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 232
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.Male or female patients aged 35 years and 70 years old. 2.Waist circumference 102 cm in men and 88 cm in women 3.Two other components of the metabolic syndrome NCEP/ATPIII definition among the following a.Triglyceridemia 150 mg/dl or 1.69 mmol/L b.HDL cholesterol 50 mg/dL or 1.29 mmol/L in women or 40 mg/dL or 1.04 mmol/L in men c.Blood pressure 130/85 mmHg systolic blood pressure 130 mmHg and/or diastolic blood pressure 85 mmHg or Treatment with antihypertensive agent s for this conditiond. Fasting blood glucose 110 mg/dl or 6.1 mmol/L
- •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
- •Related to general subjects characteristics / concomitant diseases 1.Positive pregnancy test, pregnant or breast-feeding women, or women planning to become pregnant or breastfeed 2.Absence of medically approved contraceptive methods for female of childbearing potential are considered not of childbearing potential, post-menopausal women for at least 2 years or surgically sterile 3.History of very low-calorie diet or 800 kcal/day within 3 months prior to screening visit 4.History of surgical procedures for weight loss eg, stomach stapling, bypass . 5.Presence of any clinically significant endocrine disease according to the investigator. Note euthyro d patient on replacement therapy can be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit 6.Weight change 5 kg within 3 months prior to screening visit 7.Morbid obese patients BMI 40 kg/m2 8.Established type 1 or 2 diabetes treated or untreated at least 2 measures of fasting blood glucose 126 mg/dl 9.Severe renal dysfunction creatinine clearance 30 ml/min or nephrotic syndrome 10.Chronic hepatitis or clinically significant hepatic disease 11.Positive test for hepatitis B or C 12.Marijuana or hashish users 13.Significant haematology abnormalities haemoglobin 100 g/L and/or neutrophils 1.5 G/L and/or platelets 100 G/L . 14.Inability to follow verbal and written instructions 15.Presence of any severe medical or psychological condition, that in the opinion of the Investigator would compromise the subject s safety compliance to the protocol or successful participation in the study 16.Presence or history of cancer within the past 5 years with the exception of adequately treated basal cell skin cancer or in situ uterine cervical cancer 17.Presence or history of severe depression that can be defined as depression which necessitated the patient to be hospitalised, or patient with 2 or more recurrent episodes of depression or an history of suicide attempt 18.Presence or history of bulimia or anorexia nervosa DSM-IV criteria or binge eating disorders 19.Presence of any other condition eg geographical, social current or anticipated that the Investigator feels that would restrict or limit the subject s participation for the duration of the studyRelated to previous or concomitant drugs that could interfere with the evaluation of study drug effects 20.Administration of any investigational treatment drug or device within 30 days prior to screening 21.Previous participation in a rimonabant study 22.Administration of any of the following within 3 months prior to screening visit -anti obesity drugs eg, sibutramine, orlistat -other drugs for weight reduction phentermine, amphetamines -herbal preparations for weight reduction-thyroid preparations or thyroxin treatment except in patients on replacement therapy on a stable dose 23.Patient treated within the last 3 months with nicotinic acid, fibrates, bile acid sequestrants or ezetimibe patients treated with statins can be included if the dose received is stable since at least 3 months and should not be modified during the whole study period . 24.Patient treated with antidiabetic drug s . 25.Prolonged use more than one week within the last 3 months of systemic corticosteroids, neuroleptics, or antidepressants including bupropion .
研究者
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