Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Mean Change in Level: Week 16-baseline in Ena-78
研究概览
简要总结
The purpose of the study is to test whether atorvastatin (also known as Lipitor) has anti-inflammatory effects in people with no known heart disease or high cholesterol. We also are investigating whether or not genetic differences between people plays a role in the drug response.
详细描述
All subjects received 16 weeks of Atorvastatin after a two week run in. Key dependent variables were the 16 week value minus the baseline value (post run-in). Last observation carried forward was used for missing values. The key comparisons are for two groups OATP1B1 reduced carriers and on-carriers and their association with Cytokines and Lipids. Secondarily, we were interested in changes over the 16 weeks for the pooled sample, irrespective of genetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18+ years old
- •Normocholesterolemic
排除标准
- •Cardiovascular disease or risk equivalents
- •Malignancy
- •Active alcohol abuse
- •Contraindications to statins
- •Interacting drugs
- •Chronic anti-inflammatory drugs
研究组 & 干预措施
atorvastatin
80mg of atorvastatin given once daily for 16 weeks
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Mean Change in Level: Week 16-baseline in Ena-78
时间窗: 16 weeks after baseline
We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.
次要结局
未报告次要终点