The 8 Weeks, Multicenter, Randomized, Double-blind, Clinical Study To Evaluate Efficacy Of Treatment With Losartan/Amlodipine 100/5 mg Combination Compared To Amlodipine 10 mg Monotherapy In Hypertensive Patients Who Are Not Appropriately Respond To Amlodipine 5 mg Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 334
- 主要终点
- Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
研究概览
简要总结
This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Losartan/amlodipine Treatment Arm
One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
干预措施: Losartan (+) amlodipine (Drug)
Losartan/amlodipine Treatment Arm
One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
干预措施: Placebo to match amlodipine (Drug)
Amlodipine Treatment Arm
2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
干预措施: Placebo to match losartan/amlodipine tablets (Drug)
Amlodipine Treatment Arm
2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
干预措施: Amlodipine camsylate (Drug)
结局指标
主要结局
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
时间窗: Baseline and Week 8
Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
次要结局
- Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4(Baseline and Week 4)
- Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4(Baseline and Week 4)
- Change From Baseline in Ankle Circumference at Week 8(Baseline and Week 8)
- Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8(Baseline and Week 8)
- Percentage of Participants Who Achieve Target Blood Pressure at Week 8(Week 8)
- Percentage of Participants Who Achieve Target Blood Pressure at Week 4(Week 4)
- Percentage of Participants Who Had Peripheral Edema During the Study(up to 8 weeks)