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临床试验/NCT00444717
NCT00444717已完成4 期

Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

Aichi Gakuin University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年4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
100
试验地点
2
主要终点
Thiobarbituric acid reactive substance; high sensitive C-reactive protein

研究概览

简要总结

The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.

详细描述

The metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. Recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. Statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. Pitavastatin, a chemically synthesized statin, has potent LDL-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. However, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.

研究设计

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

入排标准

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

入选标准

  • Hypercholesterolemic patients

排除标准

  • Patients receiving lipid-lowering agents
  • Familial hypercholesterolemia
  • Renal disease
  • Diseases of liver, gallbladder and bile ducts
  • Pregnant women

结局指标

主要结局

Thiobarbituric acid reactive substance; high sensitive C-reactive protein

时间窗: 12 weeks

次要结局

  • Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;(12 weeks)
  • Homeostasis model assessment for insulin resistance; adiponectin;(12 weeks)
  • Soluble intercellular adhesion molecule-1(12 weeks)

研究者

申办方类型
Other

研究点 (2)

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