JPRN-UMIN000007302已完成未知
Clinical study of atorvastatin on patients with hyperlipidemia. Comparison of the efficacy and safety between the original drug and its generic drug - Comparative study between the original drug of atorvastatin and its generic drug
agano Kidney Evaluation Association (NKEA)0 个研究点目标入组 100 人开始时间: 2012年2月26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
- 100
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
- 年龄范围
- 20years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Familial hypercholesteremia (2) Secondary hyperlipidemia or drug-induced hyperlipidemia (3) Fasting serum triglyceride <= 400 mg/dL (4) A history of stroke, ischemic heart disease or cerebral embolism during the previous 24 weeks (5) One of the following severe diseases; Cancer, hypertension (SAP <= 180 mmHg or DBP <= 110 mmHg), Type I diabetes, severe liver disease (ALT/AST <= 100 IU/L and T-Bil < 2.5 mg/dL), and renal dysfunction (eGFR > 30 mL/min/1.73 m2) (6) A history of hypersensitivity to statins (7) A patient who is not candidates for Lipitor therapy (8) Treatment with cyclosporine (9) Serum CK (CKP) < 1,000 IU/L (10) Hypothyroidism, inherited myopathy or a history of drug-induced myopathy (11) Pregnant, breast-feeding, becoming pregnant (12) Inadequate to this study
研究者
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