NCT06955104已完成3 期
A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients With Dyslipidemia
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2025年4月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Percent change from baseline in LDL-C
研究概览
简要总结
A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients with Dyslipidemia
详细描述
To evaluate the efficacy and safety of JW0108+C2407 in dyslipidemia patients
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 19 years old at the time of written informed consent
- •Patients with dyslipidemia
排除标准
- •Secondary dyslipidemia
- •Patient who does not meet the specified TG, LDL-C level
研究组 & 干预措施
Experimental Group: JW0108 + C2407
Experimental
For 8weeks QD(Quaque Die)
干预措施: JW0108 + C2407 (Drug)
Control Group: JW0108 + C2407 placebo
Active Comparator
For 8weeks QD(Quaque Die)
干预措施: JW0108 + C2407 placebo (Drug)
结局指标
主要结局
Percent change from baseline in LDL-C
时间窗: Week 8
Check LDL-C
次要结局
- Efficacy and Safety: Change from baseline in LDL-C (mg/dL)(Week 8)
研究者
研究点 (1)
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