NCT01131546已完成4 期
A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients)
研究概览
简要总结
This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or 5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential hypertension.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients, 18-75 Years
- •Patients with mild to moderate essential hypertension (defined as mean BP of 2 visits ≥140mm/90mmHg, and < 180mm/110mmHg)
- •Written informed consent
排除标准
- •Patients with secondary hypertension
- •Patients with severe hypertension
- •Have to take other drugs that can influence blood pressure during the study
- •Allergic to DHP calcium antagonists
- •Evidence of congestive heart failure, unstable angina or severe arrhythmia
- •Renal or hepatic dysfunction
- •Women who are taking contraceptive pills or are likely to be pregnant
- •Participate in other clinical trials within 3 months prior to this study
研究组 & 干预措施
Levamlodipine besylate (2.5mg)
Experimental
干预措施: Levamlodipine besylate (Drug)
Levamlodipine besylate (5mg)
Experimental
干预措施: Levamlodipine besylate (Drug)
Amlodipine maleate (5mg)
Active Comparator
干预措施: Amlodipine maleate (Drug)
结局指标
主要结局
Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients)
时间窗: Week 8
次要结局
- Change from baseline in diastolic blood pressure (DBP)(Week 8)
- Change from baseline in systolic blood pressure (SBP)(Week 8)
- Incidence of adverse effects(8 weeks)
研究者
研究点 (1)
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