A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy in Patients With Hypertension and Primary Hypercholesterolemia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol
研究概览
简要总结
The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy in patient with hypertension and 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
- •Both man and woman who is over 19years old.
- •Hypertension with primary cholesterolemia and satisfy the lab results that Mean msSBP is under 180mmHg and Mean msDBP is under 110mmHg and LDL-C is 250mg/DL or under and Triglycerides is under 400mg/dL
排除标准
- •Therapeutic lifestylechange is not enought during the study period
- •SBP difference is bigger than 20mmHg or DBP difference is bigger than 10mmHg at screening visit
研究组 & 干预措施
PR group
DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg
干预措施: DP-R208 Placebo (Drug)
CR group
DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla
干预措施: DP-R208 (Drug)
CR group
DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla
干预措施: Candesartan32mg Placebo (Drug)
CR group
DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla
干预措施: Rosuvastatin 20mg Placebo (Drug)
CP group
DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla
干预措施: Candesartan32mg (Drug)
CP group
DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla
干预措施: DP-R208 Placebo (Drug)
CP group
DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla
干预措施: Rosuvastatin 20mg Placebo (Drug)
PR group
DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg
干预措施: Rosuvastatin 20mg (Drug)
PR group
DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg
干预措施: Candesartan32mg Placebo (Drug)
结局指标
主要结局
Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol
时间窗: 8weeks
次要结局
未报告次要终点