EUCTR2006-002007-13-DE进行中（未招募）不适用
A randomized, active-controlled, open-label, multicenter cross-over study with two 6-week treatment periods to investigate the effect of the combination of Lescol XL (fluvastatin) 80 mg and fenofibrate 200 mg on HDL-C in comparison to the combination of simvastatin 20 mg and ezetimibe 10 mg in patients with metabolic syndrome
ovartis Pharma GmbH0 个研究点目标入组 70 人开始时间: 2006年4月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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. Written informed consent to participate in the study prior to any study procedures.
- •2. Male or female subjects, age between 18-75 years inclusive.
- •3. All women of child bearing potential must have a negative pregnancy test
- •4. Metabolic Syndrome according to the IDF definition:
- •a) Low plasma HDL-C (Men < 40 mg/dl; Women < 50 mg/dl).
- •b) Elevated waist circumference (men = 94 cm, women = 80cm)
- •c) And one ore more of the following criteria:
- •i) Triglycerides = 150 mg/dl
- •ii) Raised blood pressure (DBP = 85 mmHg and/or SBP = 130mmHg) or treated hypertension.
- •iii) FPG = 100mg/dl.
- •iv) Previously diagnosed type 2 diabetes.
- •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
- •1. Patients with homozygous familial hypercholesterolemia, and Fredrickson Types I, IV and V dyslipoproteinemia.
- •2. Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease etc.
- •3. Type 1 diabetes or secondary type 2 diabetes such as cushing syndrome
- •4. Lipid-lowering agents: A 6-week wash out period from HMG-CoA reductase inhibitors, fibrate derivatives, niacin and anti-obesity drugs is required. Patients treated with probucol should have discontinued it for at least one year.
- •5. Triglyceride levels > 1000 mg/dL (11.28 mmol/L) at week -1.
- •6. FPG > 270 mg/dL (15 mmol/L) at week -1.
- •7. HbA1c > 9.5% at week -1.
- •8. ALT/SGPT and/or AST/SGOT > 2 x ULN at Visit 2/Week -1.
- •9. Impaired renal function with a serum creatinine > 2 x ULN at Visit 2/Week -1.
- •10. Unexplained serum CPK levels >2 x ULN at Visit 2/Week -1.
- •11. History of dialysis or of nephrotic syndrome.
- •12. History or evidence of muscular or neuromuscular disease.
- •13. Malignant or poorly controlled hypertension (SBP>160mmHg, DBP >100mmHg).
- •14. History of severe cardiovascular disease (myocardial infarction, bypass surgery, coronary angioplasty, cerebral stroke, unstable angina pectoris).
- •15. History of heart failure (e.g., New York Heart Association Class II and above).
- •16. Any surgical or medical conditions which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.
- •Further exclusion criteria are defined in the study protocol
研究者
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