A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients With Essential Hypertension and Primary Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Low density lipoprotein cholesterol (LDL-C)
研究概览
简要总结
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase 3 trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia
详细描述
This trial is a phase 3 study to evaluate the efficacy and safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia.
This is multi-center, double-blind, Active-controlled, parallel-group, phase 3 study.
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
- •Patients with Essential Hypertension and Primary Hypercholesterolemia
排除标准
- •Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
- •Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
研究组 & 干预措施
HODO-2224-1+HODO-2224-2+HODO-2224-4
Oral tablet, QD
干预措施: Ezetimibe/Rosuvastatin/Candesartan/Amlodipine (Drug)
HODO-2224-1+HODO-2224-4+HODO-2224-5
Oral tablet, QD
干预措施: Candesartan/Amlodipine (Drug)
HODO-2224-2+HODO-2224-3+HODO-2224-6
Oral tablet, QD
干预措施: Candesartan/Rosuvastatin/Ezetimibe (Drug)
结局指标
主要结局
Low density lipoprotein cholesterol (LDL-C)
时间窗: baseline and week 8
LDL-C change at Week 8 compared HODO-2224-1 + HODO-2224-4 + HODO-2224-5 with HODO-2224
Mean sitting systolic blood pressure (MSSBP)
时间窗: baseline and week 8
MSSBP change at week 8 compared HODO-2224-2 + HODO-2224-3 + HODO-2224-6 with HODO-2224
次要结局
- change of other Lipid profile(0, 4, 8 weeks)