NCT05400317招募中3 期
A Randomized, Double-blinded, Active-controlled, Multicenter Phase 3 Clinical Trial and Open-label, Extension Study to Evaluate the Efficacy and Safety of AD-218 in Patients with Mixed Dyslipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Percent change (%) of non-HDL-C from baseline at week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of AD-218
详细描述
Condition or disease : Mixed Dyslipidemia Treatment Drug : AD-218, AD-218A, Placebo of AD-218, Placebo of AD-218A
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A man or woman over 19 years old.
- •Sign on ICF prior to study participation
排除标准
- •History of Fibromyalgia, Myopathy etc (CK ≥ 2 X ULN)
- •Other exclusions applied
研究组 & 干预措施
Active Comparator : Test group
Experimental
AD-218
干预措施: AD-218 (Drug)
Active Comparator : Control group
Active Comparator
AD-218A
干预措施: AD-218A (Drug)
结局指标
主要结局
Percent change (%) of non-HDL-C from baseline at week 12
时间窗: from baseline at 12 weeks
non-HDL-C at week 12 compared AD-218 with AD-218A
次要结局
- Percent change (%) of non-HDL-C from baseline at week 4, 8(from baseline at week 4,8)
- Percent change (%) of Lipid panel from baseline at week 4, 8, 12(from baseline at week 4, 8, 12)
研究者
研究点 (1)
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