Study on Optimal Anti-hypertensive Therapy With Valsartan by Using Home Blood Pressure Measurement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Improvement percentage of urinary albumin excretion
研究概览
简要总结
The purpose of this study is to compare improvement percentage of urinary albumin excretion between valsartan 80 mg- and valsartan 160 mg-based therapy in patient with morning hypertension.
详细描述
The cardiovascular diseases such as stroke and myocardial infarction consist 50% of the cause of death in Japanese population. Numerous mega trials have shown that strict anti-hypertensive therapy could reduce cardiovascular morbidity and mortality in hypertensive patients.
It is reported, however, over 50% hypertensive patients have not been controlled below therapeutic target blood pressure that the JSH2004 guideline recommends.
Recently use of Angiotensin II receptor blockers (ARBs) is increasing progressively for their pharmacological action on organ protection as well as potent reduction in blood pressure. However, usual dosage of ARB in Japan is almost half of that in the mega trials executed in Europe and America. Lower dosage compared to western countries might be a reason why cardiovascular events are not fully reduced in Japan.
Valsartan optimal therapy against elevated home blood pressure research (VOYAGER) study will be a multi-center, open-label, randomized, active-controlled study to evaluate the following; improvement percentage of urinary albumin exception, home blood pressure, hospital blood pressure, incidence of stroke, cardiovascular disease, and microangiopathy with valsartan 80 mg- or valsartan 160 mg based therapy in patients with elevated morning home blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients aged over 20 years and less than 80 years, regardless of sex.
- •Patients with stable seated morning home blood pressure of over 135 mmHg and/or diastolic blood pressure of over 85 mmHg within 1 to 2 weeks.
- •Patients who are on therapy with conventional dosage of ARB.
排除标准
- •Patients who are difficult to measure home blood pressure.
- •Patients with secondary hypertension or malignant hypertension.
- •Patients with seated systolic blood pressure of over 200 mmHg.
- •Patients with seated diastolic blood pressure of over 120 mmHg.
- •Patients with a history of cerebrovascular disorder or myocardial infarction or heart failure within 6 months prior to enrolment in the study.
- •Patients with atrial fibrillation, atrial flutter, or serious arrhythmia.
- •Patients with renal dysfunction with serum creatinine level of over 2 mg/dL.
- •Patients with serious liver dysfunction.
- •Patient with HbA1C of over 8 percent.
- •Patient with positive albuminuria by dip and read stick test.
- •Patient treated with any angiotensin converting enzyme inhibitor
- •Pregnant women
- •Patients with a history of hypersensitivity to valsartan.
- •Other patients who are judged to be inappropriate for the study by the investigator or sub-investigator.
研究组 & 干预措施
Valsartan
干预措施: Valsartan 80mg daily (Drug)
Valsartan
干预措施: Valsartan 160mg daily (Drug)
结局指标
主要结局
Improvement percentage of urinary albumin excretion
时间窗: 3, 6, 9, and 12 months
次要结局
- home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy(every month)
研究者
Koshiro Fukiyama
Honorary Director
Kitakyushu-Tsuyazaki Hospital