NCT01069783已完成2 期
A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients With Dyslipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Albireo
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline in low-density lipoprotein (LDL) cholesterol
研究概览
简要总结
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with dyslipidemia (high cholesterol 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meet protocol specified criteria for dyslipidemia and has successfully completed study requirements with no clinically relevant findings
排除标准
- •Medical history or medical condition that would not make the patient a good candidate for the study or would limit the patient´s capability to complete the study
研究组 & 干预措施
A3309 low dose
Experimental
干预措施: A3309 (Drug)
A3309 high dose
Experimental
干预措施: A3309 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in low-density lipoprotein (LDL) cholesterol
时间窗: eight weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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