A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- The change in MSSBP between baseline and Week8.
研究概览
简要总结
A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 19 years or older / 75 years or younger on screening
- •Signed informed consent
- •Patients with Essential Hypertension
- •Other inclusion applied
排除标准
- •Orthostatic hypertension with symptom
- •Other exclusion applied
研究组 & 干预措施
Irbesartan low/Amlodipine low
Irbesartan low & Amlodipine low, once daily for 8 weeks
干预措施: Irbesartan/Amlodipine (Drug)
Irbesartan low/Amlodipine high
Irbesartan low & Amlodipine high, once daily for 8 weeks
干预措施: Irbesartan/Amlodipine (Drug)
Irbesartan high/Amlodipine low
Irbesartan high & Amlodipine low, once daily for 8 weeks
干预措施: Irbesartan/Amlodipine (Drug)
Irbesartan high/Amlodipine high
Irbesartan high & Amlodipine high, once daily for 8 weeks
干预措施: Irbesartan/Amlodipine (Drug)
Amlodipine low
Amlodipine low, once daily for 8 weeks
干预措施: Irbesartan/Amlodipine (Drug)
Amlodipine high
Amlodipine high, once daily for 8 weeks
干预措施: Irbesartan/Amlodipine (Drug)
Irbesartan low
Irbesartan low, once daily for 8 weeks
干预措施: Irbesartan/Amlodipine (Drug)
Irbesartan high
Irbesartan high, once daily for 8 weeks
干预措施: Irbesartan/Amlodipine (Drug)
结局指标
主要结局
The change in MSSBP between baseline and Week8.
时间窗: Baseline and Week8
The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8.
次要结局
- The change in MSSBP between baseline and Week4.(Baseline and Week4)
- The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.(Baseline and Week4/8)
- The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8.(Baseline and Week4/8)