EUCTR2004-002535-12-AT进行中（未招募）1 期
Fluvastatin 80 mg ret. vs combination with ezetimib 10 mg
Clinical Institute of Medical and Chemical Laboratory Diagnostics Graz0 个研究点目标入组 90 人开始时间: 2004年10月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •·Patients with CHD or CHD equivalent with LDL 100-160 mg/dl
- •·Male or female sex
- •·Normal values of CK, AST and ALT
- •·Normal kidney function
- •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
- •·CHD Stage III-IV
- •·St. p. myocardial infarction or coronary artery bypass grafting
- •·Pregnancy or breastfeeding
- •·AST or ALT > 3x ULN (upper limit of normal)
- •·CPK > 5x ULN or > 3x with muscle pain, tenderness or weakness
- •·Severe renal dysfunction, nephritic syndrome
- •·Premenopausal women without certain contraception
- •·Known hypersensitivity to HMG-CoA reductase inhibitors or ezetimib
研究者
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