Double Blind, Randomized, Parallel Group, Multicentre Study to Evaluate the Effects of Manidipine 20 MG Vs. Amlodipine 10 MG and the Combination of Manidipine 10 MG Plus Delapril 30 MG Vs. Amlodipine 5 MG Plus Delapril 30 MG on Intraglomerular Pressure in Hypertensive Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure
研究概览
简要总结
Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase.
详细描述
The aim of the current study is to assess the effect of a 4-week single drug treatment with manidipine or amlodipine and a 4-week combination treatment with manidipine plus delapril or amlodipine plus delapril on intraglomerular pressure in subjects with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients aged 18 years or older
- •mild to moderate hypertension (systolic blood pressure > 139 mmHg or diastolic blood pressure > 89 mmHg)
排除标准
- •secondary form of arterial hypertension
- •severe hypertension (systolic blood pressure > 179 mmHg or diastolic blood pressure > 109 mmHg)
- •pregnant or lactating women
研究组 & 干预措施
amlodipine 10 mg
干预措施: amlodipine 10 mg (Drug)
amlodipine 10 mg
干预措施: amlodipine 5 mg + delapril 30 mg (Drug)
manidipine 20 mg
干预措施: manidipine 20 mg (Drug)
manidipine 20 mg
干预措施: manidipine 10 mg + delapril 30 mg (Drug)
结局指标
主要结局
effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure
时间窗: 4 weeks
次要结局
- effects of combination of manidipine 10 mg plus delapril 30 mg once daily compared with once daily amlodipine 5 mg plus delapril 30 mg on intraglomerular pressure(4 weeks)
研究者
Roland E. Schmieder
Prof. Dr. med.
University of Erlangen-Nürnberg Medical School