A Randomized, Double-blind, Active-controlled, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 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
- 131
- 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/Amlodipine 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/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.
In "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" for 8 weeks.
In "Rosuvastatin/Ezetimibe +Telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.
In "Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Telmisartan/Amlodipine" 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
- 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
Co-administered of AD-2071 and AD-2073
48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks.
干预措施: Ezetimibe/Rosuvastatin (Drug)
Co-administered of AD-2071 and AD-2073
48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks.
干预措施: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET (Drug)
Co-administered of AD-2071 and AD-2072
48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks.
干预措施: Ezetimibe/Rosuvastatin (Drug)
Co-administered of AD-2071 and AD-2072
48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks.
干预措施: Telmisartan (Drug)
AD-2073
48 subjects will be assigned and the subjects will be administered "AD-2073(Telmisartan/Amlodipine)" for 8 weeks.
干预措施: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET (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-2071 + AD-2073 with AD-2073
Mean sitting systolic blood pressure (MSSBP)
时间窗: Baseline, Week 8
MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073
次要结局
未报告次要终点