A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Temisartan/Amlodipine and Rosuvastatin in Subjects With Hypertension and Hyperlipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Mean sitting systolic blood pressure (MSSBP)
研究概览
简要总结
Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.
详细描述
This trial is a phase 3 study to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.
In "Temisartan/Amlodipine/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine/Rosuvastatin" 8 for weeks.
In "Temisartan/Amlodipine" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine" for 8 weeks.
In "Temisartan/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Rosuvastatin" 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)
盲法说明
Double Blind
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
- •Patients with known or suspected secondary hypertension
- •Other exclusions applied
研究组 & 干预措施
"Combination drug:Temisartan+Amlodipine+Rosuvastatin"
60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks.
干预措施: Temisartan+Amlodipine+Rosuvastatin (Combination drug) (Drug)
Temisartan+Amlodipine
60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks.
干预措施: Temisartan+Amlodipine (Drug)
Temisartan+Rosuvastatin
60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks.
干预措施: Temisartan+Rosuvastatin (Drug)
结局指标
主要结局
Mean sitting systolic blood pressure (MSSBP)
时间窗: Baseline, Week 8
MSSBP change form the baseline at Week 8
Low density lipoprotein cholesterol (LDL-C)
时间窗: Baseline, Week 8
LDL-C change form the baseline at Week 8
次要结局
- MSSBP (Mean sitting systolic blood pressure)(Baseline, Week 4)
- High density lipoprotein cholesterol (HDL-C)(Baseline, Week 4, Week 8)
- 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)
- Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)(Baseline, Week 4, Week 8)
- Triglyceride (TG)(Baseline, Week 4, Week 8)