NCT00739050终止4 期
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 主要终点
- Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
研究概览
简要总结
Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female Patients Over 18 Years Old
- •Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR)
- •Signed Informed Consent Form (ICF)
排除标准
- •Patients With LDL-C Below 90 mg/dL
- •Pregnant Or Breast Feeding
- •Diabetes Mellitus
- •Or Any Clinically Relevant Organ Disfunction
研究组 & 干预措施
1
Experimental
Arm 1: Drug
干预措施: simvastatin (Drug)
结局指标
主要结局
Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
时间窗: Baseline and 12 weeks
The study was terminated; no outcome measure data analyses were conducted.
次要结局
- Change in Total Cholesterol From Baseline at Week 12(Baseline and 12 weeks)
- Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment(Baseline and 12 weeks)
- Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment(Baseline and 12 weeks)
研究者
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