NCT00847782已完成不适用
An Experimental Medicine Study to Quantify PCSK9 Serum Concentrations and LDL Receptor Expression in Peripheral Blood Cells in Normal and Hypercholesterolemic Subjects
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Serum PCSK9 concentration
研究概览
简要总结
The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Hypercholesterolemia
- •Statin monotherapy
排除标准
- •Significant acute or chronic illness
- •Secondary causes of hypercholesterolemia
结局指标
主要结局
Serum PCSK9 concentration
时间窗: Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled
次要结局
- Serum HDL cholesterol concentration(Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects)
- Serum TG concentration(Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects)
- Serum Apo B concentration(Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects)
- Serum LDL cholesterol concentration(Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects)
研究者
研究点 (2)
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