NCT00171262已完成4 期
Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers
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
- 否
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
研究点 (1)
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