NCT00866229Unknown4 期
Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in SLE Patients With Corticosteroid Therapy and High LDL Cholesterol Level
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Percentage reduction of LDL Cholesterol level
研究概览
简要总结
Early statin therapy in SLE patients that have high cholesterol level and other atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course of disease. By the way, statin is used in restricted groups of rheumatologists due to awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients more so than other groups of atherosclerosis patients and reporting data of autoimmune diseases that occur after statin use.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SLE patients that on prednisolone more than 30 mg/day
- •Normal liver faction: AST and ALT < 80 mg/dl
- •Normal muscle enzyme : CPK < 100 U/L
- •LDL cholesterol level > 100 mg/dl
排除标准
- •Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone > 1mg/kg/day at screening.
- •Statin allergy
- •On statin treatment before screening
- •On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin
- •Pregnancy
- •Abnormal liver function: AST or ALT > 80 mg/dl
- •Abnormal muscle enzyme : CPK > 300 U/L
结局指标
主要结局
Percentage reduction of LDL Cholesterol level
时间窗: 6 and 12 weeks
次要结局
- Proportion of patients that have transminitis, myositis or active SLE(6,12, 18 and 24 weeks)
研究者
研究点 (2)
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