NCT00293878已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Effects on Lipids of 12 Weeks of 2 Doses of FM-VP4 in Subjects With Primary Hypercholesterolemia
Forbes Medi-Tech21 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 21
- 主要终点
- Percent change from baseline in LDL-C at 12 weeks
研究概览
简要总结
The purpose of this study is to evaluate the safety and effects on lipids of FM-VP4 administered for 12 weeks in subjects with mild to moderate primary hypercholesterolemia.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate primary hypercholesterolemia
- •Able to give informed consent and to comply with study procedures (including diet)
排除标准
- •Homozygous familial hypercholesterolemia
- •Age <18 or >75 years
- •Pregnant women or women of child-bearing potential
结局指标
主要结局
Percent change from baseline in LDL-C at 12 weeks
次要结局
- Percent change from baseline in serum lipids at 2, 4 and 8 weeks
- Safety
- Percent change from baseline in TC, HDL-C, TG, HDL:LDL ratio and CRP at 12 weeks
研究者
研究点 (21)
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