NCT05131997已完成3 期
A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Administrated AD-221 and AD-221A in Patients With Primary Hypercholesterolemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Low density lipoprotein cholesterol (LDL-C)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A
详细描述
The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A in patients with primary hypercholesterolemia
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
- •Signed informed consent
- •Subjects with primary hypercholesterolemia
排除标准
- •Patient with secondary dyslipidemia
- •Other exclusions applied
研究组 & 干预措施
AD-221C
Active Comparator
AD-221C, Placebo of AD-221, AD-221A and AD-221B
干预措施: AD-221C (Drug)
AD-221
Experimental
AD-221, Placebo of AD-221A, AD-221B and AD-221C
干预措施: AD-221 (Drug)
AD-221A
Experimental
AD-221A, Placebo of AD-221, AD-221B and AD-221C
干预措施: AD-221A (Drug)
AD-221B
Active Comparator
AD-221B, Placebo of AD-221, AD-221A and AD-221C
干预措施: AD-221B (Drug)
结局指标
主要结局
Low density lipoprotein cholesterol (LDL-C)
时间窗: Baseline, Week 8
LDL-C change at Week 8
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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