NCT04161001Unknown3 期
A Multi-center, Randomized, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ1451 in Patients With Hypertension and Dyslipidemia
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2019年11月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- the change of MSSBP based on baseline between Treatment arm and control 1 arm
研究概览
简要总结
- the change of sitSBP based on baseline between Treatment arm and control 1 arm [ Time Frame: 8 weeks ]
- the change of LDL-C based on baseline between Treatment arm and control2 arm [ Time Frame: 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 to 80 years
- •patients with hypertension and hyperlipidemias
排除标准
- •orthostatic hypotension
- •History of ventricular tachycardia, atrial fibrillation
- •uncontrolled diabetes mellitus
研究组 & 干预措施
Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe
Experimental
co-administration of Olmesartan, Amlodipine and Rosuvastatin, Ezetimibe
干预措施: Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug) (Drug)
Olmesartan, Rosuvastatin, Ezetimibe
Placebo Comparator
co-administration of Olmesartan and Rosuvastatin, Ezetimibe
干预措施: Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug) (Drug)
Amlodpine, Olmesartan
Placebo Comparator
co-administration of Olmesartan, Amlodipine
干预措施: Amlodipine/Olmesartan 10/40mg (Combination drug) (Drug)
结局指标
主要结局
the change of MSSBP based on baseline between Treatment arm and control 1 arm
时间窗: 8 weeks
the change of LDL-C based on baseline between Treatment arm and control2 arm
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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