A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022 in Patients With Primary Hypercholesterolemia and Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 109
- 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 Co-administrated AD-2021 and AD-2022
详细描述
Condition or disease : Primary Hypercholesterolemia and Essential Hypertension Intervention/treatment Drug : AD-2021 Drug : AD-2022 Drug : AD-2021 Placebo Drug : AD-2022 Placebo Phase : Phase 3
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
- •Signed informed consent
- •Subjects with hypertension and hyperlipidemia
排除标准
- •Patient with known or suspected secondary hypertension
- •Other exclusions applied
研究组 & 干预措施
Active Comparator 2
AD-2022, AD-2021 placebo
干预措施: AD-2022 (Drug)
Active Comparator 2
AD-2022, AD-2021 placebo
干预措施: AD-2021 Placebo (Drug)
Active Comparator 1
AD-2021, AD-2022 placebo
干预措施: AD-2021 (Drug)
Active Comparator 1
AD-2021, AD-2022 placebo
干预措施: AD-2022 Placebo (Drug)
Experimental 1
AD-2021, AD-2022
干预措施: AD-2021 (Drug)
Experimental 1
AD-2021, AD-2022
干预措施: AD-2022 (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 compared AD-2021 + AD-2022 with AD-2022
Mean sitting systolic blood pressure (MSSBP)
时间窗: Baseline, Week 8
MSSBP change at Week 8 compared AD-2021 + AD-2022 with AD-2021
次要结局
未报告次要终点