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临床试验/NCT00171262
NCT00171262已完成4 期

Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Novartis1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2004年8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
发起方
Novartis
入组人数
120
试验地点
1
主要终点
Change from baseline in serum inflammatory markers after 52 weeks

研究概览

简要总结

To analyze efficacy of fluvastatin on patients with chronic renal disease by analyzing certain inflammatory markers. In addition, tolerability and safety will also be evaluated in a Spanish population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

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

入选标准

  • Patients > 18 years Patients that give their inform consent

排除标准

  • Pregnant women Diabetic patients Treated with statins for the year prior to study inclusion Patients with contraindications listed in fluvastatin prescribing information
  • Other protocol-defined in and exclusion criteria may apply

结局指标

主要结局

Change from baseline in serum inflammatory markers after 52 weeks

次要结局

  • Adverse events and serious adverse events after 52 weeks
  • Change from baseline in fibrosis parameters and endothelial function after 52 weeks
  • Change from baseline in laboratory tests of kidney function after 12 weeks

研究者

发起方
Novartis
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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