ISRCTN63367873已完成不适用
CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE
niversity Maastricht (UM) (The Netherlands)0 个研究点目标入组 600 人开始时间: 2006年12月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •We aim to include people who fulfil at least the following inclusion criteria:
- •1. Informed consent must be obtained in writing for all subjects at enrolment into the study
- •2. Male or female 18 to 75 years of age
- •3. Willingness and ability to comply with the study protocol (including the lifestyle counselling)
- •4. Waist circumference more than 88 cm in women and more than 102 cm in men
- •5. Diabetes mellitus type two or an impaired fasting blood glucose more than 6.1 mmol/l in venous plasma
排除标准
- •Participants are excluded from participation in the study if:
- •1. Pregnant or breast-feeding women, or women planning to become pregnant
- •2. Previous use of rimonabant
- •3. History of surgical procedures for weight loss (e.g., stomach stapling, bypass)
- •4. Morbid obese patients (Body Mass Index [BMI] more than 40 kg/m^2), history of bulimia or anorexia nervosa
- •5. Presence of any clinically significant endocrine disease
- •6. Severe renal dysfunction (creatinine clearance more than 30 ml/min) or nephrotic syndrome
- •7. Known chronic hepatitis or clinically significant hepatic disease
- •8. Significant haematology abnormalities (haemoglobin less than 100 g/L and/or neutrophils less than 1.5 G/L and/or platelets less than 100 G/L)
- •9. Cardiac status New York Heart Association (NYHA) III or IV or Electrocardiogram (ECG) within six months showing acute changes
- •10. Any current malignancy or any cancer with the past five years (except adequately treated basal cell skin cancer or cervical carcinoma in situ)
- •11. History of seizure disorder
- •12. Acute psychiatric disorders or prolonged use within the last three months of neuroleptics
- •13. History of severe depression that could be defined as depression which necessitated the patient to be hospitalised, or patients with two or more recurrent episodes of depression or a history of suicide attempt and/or prolonged use (more than one week) within the last three months use of antidepressants (including bupropion)
- •14. History of alcohol or other substance abuse, use of hashish or marijuana use
- •15. Use of any investigational treatment (drug or device) within 30 days prior to screening
- •16. Prolonged use (more than one week) within the last three months of systemic corticosteroids
研究者
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