A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan 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
- 180
- 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 Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.
详细描述
This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.
In "Rosuvastatin/Ezetimibe+Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.
In "Rosuvastatin/Ezetimibe" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe" for 8 weeks.
In "Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Telmisartan" for 8 weeks.
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 hypertension and hyperlipidemia
排除标准
- •Patient with known or suspected secondary hypertension
- •Other exclusions applied
研究组 & 干预措施
Ezetimibe/Rosuvastatin and Telmisartan
60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin and Telmisartan" for 8 weeks.
干预措施: Ezetimibe/Rosuvastatin (Drug)
Ezetimibe/Rosuvastatin and Telmisartan
60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin and Telmisartan" for 8 weeks.
干预措施: Telmisartan (Drug)
Ezetimibe/Rosuvastatin
60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin" for 8 weeks.
干预措施: Ezetimibe/Rosuvastatin (Drug)
Telmisartan
60 subjects will be assigned and the subjects will be administered "Telmisartan" for 8 weeks.
干预措施: Telmisartan (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 to Baseline
Mean sitting systolic blood pressure (MSSBP)
时间窗: Baseline, Week 8
MSSBP change at Week 8 compared to Baseline
次要结局
- Mean sitting diastolic blood pressure (MSDBP)(Baseline, Week 4, Week 8)
- Low density lipoprotein cholesterol (LDL-C)(Baseline, Week 4)
- Total Cholesterol (TC)(Baseline, Week 4, Week 8)
- Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)(Baseline, Week 4, Week 8)
- Mean sitting systolic blood pressure (MSSBP)(Baseline, Week 4)
- High density lipoprotein cholesterol (HDL-C)(Baseline, Week 4, Week 8)
- Triglyceride (TG)(Baseline, Week 4, Week 8)
- Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)(Baseline, Week 4, Week 8)