NCT06717360已完成3 期
A Multicenter, Randomized, Double-blinded, Active-controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients With Primary Hypercholesterolemia
Ahn-Gook Pharmaceuticals Co.,Ltd1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2024年9月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- LDL-C level
研究概览
简要总结
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19-80
- •Patients with primary hypercholesterolemia
- •Those who voluntarily written consent to participate in this clinical trial
排除标准
- •The subject not meet the specified LDL-C level
- •Other exclusions applied
研究组 & 干预措施
AG2304T
Experimental
干预措施: AG2304T (Drug)
AG2304R
Active Comparator
干预措施: AG2304R (Drug)
结局指标
主要结局
LDL-C level
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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