A Randomized, Double-blind, Multi-center, Phase III Trial to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Mean sitting systolic blood pressure
研究概览
简要总结
The objective of this clinical study is to evaluate the efficacy and safety by comparing BR1017A+BR1017B treatment group to BR1017A treatment group and BR1017B treatment group respectively at Week 8 in essential hypertension 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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fimasartan/Ezetimibe/Atorvastatin
BR1017A+BR1017B(Experimental Group)
干预措施: Fimasartan (Drug)
Fimasartan/Ezetimibe/Atorvastatin
BR1017A+BR1017B(Experimental Group)
干预措施: Ezetimibe/Atorvastatin (Drug)
Fimasartan
BR1017A(Control Group 2)
干预措施: Fimasartan (Drug)
Fimasartan
BR1017A(Control Group 2)
干预措施: Ezetimibe/Atorvastatin Placebo (Drug)
Ezetimibe/Atorvastatin
BR1017B(Control Group 1)
干预措施: Ezetimibe/Atorvastatin (Drug)
Ezetimibe/Atorvastatin
BR1017B(Control Group 1)
干预措施: Fimasartan Placebo (Drug)
结局指标
主要结局
Mean sitting systolic blood pressure
时间窗: 8weeks from Baseline Visit
The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B
LDL-C
时间窗: 8weeks from Baseline Visit
The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A
次要结局
- LDL-C(8weeks from Baseline Visit)
- Mean sitting systolic blood pressure(8weeks from Baseline Visit)