Effects of the New Angiotensin II Receptor Blocker Azilsartan Versus Valsartan on Blood Pressure in Japanese Patients With Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Office Blood Pressure
研究概览
简要总结
The purpose of this study is to compare blood pressure lowering effect of azilsartan with that of valsartan in Japanese patients with hypertension who have already taken normal-dose angiotensin II receptor blockers.
详细描述
Hypertension plays a major role in the development of cardiovascular disease. Several guidelines require strict control of blood pressure for preventing cardiovascular events; however, the control is often poor.
A new angiotensin II receptor blocker (ARB), azilsartan, is the first drug which is superior to other ARBs in blood pressure lowering in phase III clinical trials in Japan. We try to evaluate effect of azilsartan on blood pressure lowering in Japanese patients with hypertension who have already taken normal-dose ARBs, and to compare it with that of valsartan.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive patients treated with normal-dose angiotensin II receptor blockers (ARBs) in Japan
- •Normal-dose ARBs in Japan are defined as follows: losartan potassium 50 mg, candesartan cilexetil 8 mg, valsartan 80 mg, telmisartan 40 mg, olmesartan medoxomil 20 mg, or irbesartan 100mg per day.
排除标准
- •Hypersensitivity for azilsartan and valsartan
- •Pregnant female
- •History of azilsartan use within 3 months
研究组 & 干预措施
Azilsartan group
干预措施: Azilsartan (Drug)
Valsartan group
干预措施: Valsartan (Drug)
结局指标
主要结局
Change in Office Blood Pressure
时间窗: Baseline and every 2 weeks (up to 12 weeks)
Change in blood pressure measured at a clinic
次要结局
- Change in Fasting Triglyceride(Baseline and 12 weeks)
- Change in Renal Function(Baseline and 12 weeks)
- Change in Glycemic Control(Baseline and 12 weeks)
- Change in Plasma Aldosterone Concentration(Baseline and 12 weeks)
- Change in Home Blood Pressure(Baseline and every 2 weeks (up to 12 weeks))
研究者
Yoshihiko Saito
Professor
Nara Medical University