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临床试验/JPRN-UMIN000007302
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

发起方
agano Kidney Evaluation Association (NKEA)

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