NCT04511000已完成4 期
A Randomized, Open-label, Parallel, Multi-Center Phase IV Study to Compare of the Efficacy and Safety of Lipilou 20 mg and Lipilou 10 mg in High-risk Patients With Hypercholesterolemia(PEARL Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 10
- 主要终点
- Change rate in LDL-C
研究概览
简要总结
This study was designed to compare the mean percent change of LDL-C between Lipilou® 10mg and 20mg group after 12 weeks of treatment.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had hypercholesterolemia with high risk, according to the 2015 Korean guidelines for managing dyslipidemia.
排除标准
- •Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction.
- •Patients who are legally unable to participate in clinical trials or who are unable to participate in clinical trials based on investigator's decision.
研究组 & 干预措施
Experimental group
Experimental
干预措施: Lipilou®(generic atorvastatin drug) 20 mg (Drug)
Comparator group
Active Comparator
干预措施: Lipilou®(generic atorvastatin drug) 10 mg (Drug)
结局指标
主要结局
Change rate in LDL-C
时间窗: 12 weeks of treatment
compare experimental group with comparator group
次要结局
未报告次要终点
研究者
研究点 (10)
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