Comparative Trial of Combination Therapy of ARB/Diuretic Versus ARB/CCB in Uncontrolled Hypertensive Patients With Monotherapy of ARB
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- The change of systolic blood pressure
研究概览
简要总结
The purpose of this study is to compare the effect and safety of the antihypertensive combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.
详细描述
The combination therapy with multiple antihypertensive drugs is recommended in the patients who are uncontrolled with monotherapy. Diuretics increase the activities of renin-angiotensin-aldosterone system (RAS), and angiotensin receptor blockers (ARB) depress blood pressure potently in the state of increased RAS activities. Thus, the combination therapy with ARB and diuretics is expected to lower the blood pressure synergistically. This combination therapy is also expected to reduce the side effects of each drug. In this study, we will compare the effect and safety of the combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under treatment of hypertension with ARB monotherapy for more than one month.
- •systolic blood pressure more than 140mmHg and less than 160mmHg or diastolic blood pressure more than 90mmHg and less than 100mmHg in sitting position.
- •In diabetic or CKD patients, systolic blood pressure more than 130mmHg and less than 160mmHg or diastolic blood pressure more than 80mmHg and less than 100mmHg in sitting position.
排除标准
- •uncontrolled hypertension (diastolic blood pressure >120mmHg)
- •uncontrolled diabetes mellitus (HbA1c>9.0%)
- •Acute myocardial infarction, stroke and other cardiovascular events within six months
- •The history of gout, or uric acid>8.0mg/dl
- •Serum creatinine>2.0mg/dl
- •sever liver dysfunction
- •Bilateral renovascular stenosis
- •secondary hypertension
- •malignant hypertension
- •uncontrolled arrhythmia
- •pregnancy or possibility of pregnancy
- •hypersensitivity to trial drug
研究组 & 干预措施
Losartan/hydrochlorothiazide
Combination drug with losartan 50mg and hydrochlorothiazide 12.5mg
干预措施: Losartan/amlodipine or losartan/hydrochlorothiazide (Drug)
Losartan/amlodipine
Combination therapy with losartan 50mg and amlodopine 5mg
干预措施: Losartan/amlodipine or losartan/hydrochlorothiazide (Drug)
结局指标
主要结局
The change of systolic blood pressure
时间窗: three months
次要结局
- The change of blood pressure(six months, nine months and one year)
- The achievement rate of target blood pressure(six months, nine months and one year)
- The change of diastolic blood pressure(three months)
研究者
Satoshi Umemura
Professor
Yokohama City University Medical Center