NCT02241772已完成1 期
A Study on the Effects of TA-8995 on Lp(a) in Subjects With Elevated Lp(a)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Xention Ltd
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995.
研究概览
简要总结
A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a) levels.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and female (of non-child bearing potential) subjects with elevated Lp(a) levels
排除标准
- •Clinically significant medical history
- •Abnormal laboratory results (other than lipid levels) or vital signs
- •Receiving any other drug therapy
研究组 & 干预措施
10mg TA-8995
Experimental
10mg TA-8995 once daily
干预措施: TA-8995 (Drug)
2.5mg TA-8995
Experimental
2.5mg TA-8995 once daily
干预措施: TA-8995 (Drug)
Placebo to TA-8995
Placebo Comparator
Placebo to TA-8995 once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995.
时间窗: 12 weeks
次要结局
- Number of participants with adverse events(12 weeks)
研究者
研究点 (1)
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