EUCTR2005-002568-27-GB进行中（未招募）1 期
A randomized, double blind, two-arm placebo controlled, 12-Month study of the effects of rimonabant 20mg once daily on the amount and the activity of visceral fat in abdominally obese patients with metabolic syndrome. - VICTORIA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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
入选标准
- •1. Male or female patients aged >or=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 >or= 150 mg/dl (or 1.69 mmol/L)
- •b. HDL cholesterol < 50mg/dL (or 1.29 mmol/L) in women or < 40mg/dL (or 1.04 mmol/L) in men
- •c. Blood pressure >or= 130/85 mmHg (systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 85 mmHg) or Treatment with antihypertensive agent(s) for this condition
- •d. Fasting blood glucose > 110 mg/dl (or 6.1 mmol/L)
- •4. 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
- •Related to general subjects characteristics / concomitant diseases:
- •1. 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
- •3. History of very low-calorie diet 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.
- •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. Ongoing 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 bing 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 study
- •Related 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 or bile acid sequestrants (patients treated with statins can be included if the dose received is stable since at least 3 months and will 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, neur
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