ISRCTN51822988已完成未知
A double-blind placebo-controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin-dependent diabetes mellitus
eiden University Medical Centre (LUMC) (Netherlands)0 个研究点目标入组 250 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
2004 Results article in https://pubmed.ncbi.nlm.nih.gov/15562202 2005 Results article in https://pubmed.ncbi.nlm.nih.gov/15983318 2005 Results article in https://pubmed.ncbi.nlm.nih.gov/15983319
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patient with Non-Insulin Dependent Diabetes Mellitus. The diagnosis is based upon:
- •1.1. The age of onset
- •1.2. The presence of obesity
- •1.3. The absence of ketoacidosis at the time of diagnosis
- •1.4. The use of diet or oral anti-diabetic drugs for more than one year from diagnosis
- •2. Males and females
- •3. Age range: 30 - 80 years
- •4. Given written informed consent
排除标准
- •1. Angina pectoris
- •2. History of myocardial infarction, Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Graft (CABG)
- •3. Positive Electrocardiogram (ECG) criteria for a myocardial infarction in the past
- •4. History of ischemic Cerebrovascular Accident (CVA)
- •5. Peripheral artery by-pass surgery or amputation because of atherosclerotic disease or claudication
- •6. Secondary diabetes (steroid induced, Cushing, haemochromatosis, alcohol abuse, pancreatitis)
- •7. Untreated or uncontrolled hyperthyroidism or hypothyroidism
- •8. Active liver disease (hepatitis, cirrhosis or biliary obstruction) or hepatic dysfunction (repeated aminotransferase-values more than 150% of the Upper Limit of Normal [ULN])
- •9. Impaired renal function with creatinine clearance less than 30 ml/min
- •10. Baseline Creatine Kinase (CK) values more than 3 x ULN
- •11. Fasting total cholesterol above 69 mmol/l despite diet or below 40 mmol/l or triglycerides above 60 mmol/l
- •12. Any hereditary dyslipidemia
- •13. Known allergy to 3-Hydroxy-3-Methyl-Glutaryl (HMG)-CoA-reductase inhibitors
- •14. Pregnancy or lactation
- •15. Women of childbearing potential, not using adequate contraceptives
- •16. Use of lipid lowering medication, within eight weeks before the start of the study
- •17. Life expectancy of less than two years
- •18. Any other condition that in the opinion of the investigator could lead to inappropriate absorption, metabolism or elimination of the medication or compromise the patients' safety or lead to insufficient compliance with the study drug regimen
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