Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 13,542
- 试验地点
- 1
- 主要终点
- The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death.
研究概览
简要总结
The aim of the study is to investigate the optimized treatment strategy of hypertension, so as to make more patients to reach the blood pressure goals and to reduce cardio-cerebrovascular events. Objective and Methods: Patients are eligible for inclusion in the study if they are essential hypertension, 50-79 years of age with at least one cardiovascular risk factor and sign the informed consent forms. This project is a multi-centre, prospective randomized,，openlabel blind-endpoint evaluation controlled (PROBE) trial. 12000 patients will be randomly assigned to either of low-dose Amlodipine+Telmisartan group or Amlodipine+ diuretics group. Among those patients with serum cholesterol between 4.0-6.1mmol/L, they will be also randomized into small dose of statin-based regimen or standard management regimen; Patients will also randomly assigned to intensive lifestyle intervention group or standard intervention group according to the community area where the patients in.
详细描述
This study is aimed to observe the main outcome (stroke, myocardial infarction and death from cardiovascular disease) differences between different groups.
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
- None
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •essential hypertension
- •50-79 years old
- •with at least one of the cardiovascular risk factor
- •sign consent forms
排除标准
- •secondary hypertension
- •attack of cerebrovascular events or myocardial infarction within recent 3 months
- •coexistence of severe cardiomyopathy, rheumatic or congenital heart diseases
- •unstable angina
- •severe hepatopathy or nephropathy (ALT elevation > 2 fold or serum creatinine > 2.5mg/dl)
- •malignant tumor
- •women taking contraceptives or with pregnancy
- •allergic history to the research drugs
- •validated contradiction to the research drugs
- •participating in other clinical trials
- •unable for long-term follow-up or poor compliance
- •unsuitable for clinical trial at the discretion of doctors in charge
研究组 & 干预措施
A,1,IV
A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV
干预措施: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin (Drug)
A,2,IV
A means active; 2 means Amlodipine+Telmisartan; IV means phase IV
干预措施: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin (Drug)
A,3,IV
A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV
干预措施: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin (Drug)
A,4,IV
A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV
干预措施: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin (Drug)
结局指标
主要结局
The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death.
时间窗: 3-4 years
次要结局
- All cardiovascular events；all-cause death, hospitalization for angina pectoris, coronary revascularization, aortic dissection, cerebrovascular disease, heart failure, renal insufficiency, tumor, new onset of atrial fibrillation and diabetes mellitus(3-4 years)
研究者
Ma Liyuan
Dr
Chinese Academy of Medical Sciences, Fuwai Hospital