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临床试验/NCT00276133
NCT00276133已完成4 期

Effects of Atorvastatin Versus Probucol on Low-Density Lipoprotein Subtype Distribution and Renal Function in Hyperlipidemic Patients With Non-Diabetic Nephropathy

Yokohama City University Medical Center1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2004年1月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Normalization of serum cholesterol concentrations

研究概览

简要总结

Small dense low-density lipoprotein (LDL) plays an important role in causing glomerular injury through conversion to an oxidatively modified form of LDL. However, few studies evaluated the effects of antilipidemic agents on the LDL particle size and renoprotective actions in hyperlipidemic patients with non-diabetic nephropathy.

详细描述

The study is a randomized crossover trial comparing the effect of atorvastatin (10 mg/day) and probucol (500 mg/day) for 24 weeks in 30 patients (urinary albumin excretion 0.3-2.0 g/day, and creatinine clearance > 30 ml/min/1.73 m2 or serum creatinine concentration < 2 mg/L). Lipid parameters, mean LDL particle diameter, creatinine clearance, and urinary albumin to creatinine excretion ratio are measured before and during treatment periods. It will be evaluated that, first, whether atorvastatin and probucol significantly reduce serum total cholesterol and LDL cholesterol concentrations, second, whether atorvastatin and probucol significantly increase the LDL particle size, third, whether significant differences in urinary albumin/creatinine excretion ratio and creatinine clearance are observed in both groups during treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Hyperlipidemic patients with non-diabetic nephropathy

排除标准

  • •Endocrinological, hematological or hepatic disease
  • •Cerebral infarction or hemorrhage
  • •Homozygous familial hypercholesterolemia
  • •Uncontrolled hypertension
  • •Myocardial infarction occurring within the previous 6 months
  • •Unstable angina
  • •Diabetic nephropathy
  • •Abnormal thyroid function
  • •Receiving steroids or immunosuppressive agents

结局指标

主要结局

Normalization of serum cholesterol concentrations

时间窗: One year

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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