NCT00125125已完成4 期
Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake
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
- 218
- 试验地点
- 3
- 主要终点
- Change from baseline in low density lipoprotein cholesterol after 12 weeks
研究概览
简要总结
The purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dyslipidemia
- •History of Myalgia
排除标准
- •Previous treatment with fluvastatin
- •Age < 18 years
- •Other protocol-defined inclusion and exclusion criteria may apply.
结局指标
主要结局
Change from baseline in low density lipoprotein cholesterol after 12 weeks
次要结局
- Number of patients who reach target LDL after 12 weeks
- Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks
- Tolerability as assessed by muscle-related adverse events, and muscle-related adverse events leading to discontinuation
- Change from baseline in marker of inflammation after 12 weeks
研究者
研究点 (3)
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