NCT01541189已完成4 期
A 8-week, Multi Center(10),Single Arm, Open-labeled Prospective Study of Valsartan 160 mg in 200 Mild to Moderate Chinese Hypertension Patients Forced Titrated From 2-week Therapy of Valsartan 80 mg.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline and week 2 in blood pressure at week 10
研究概览
简要总结
To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Naive primary hypertension patients or primary hypertensive patients on mono antihypertensive therapy:
- •All treatment-naive patients need to have 140mmHg≤MSSBP<180mmHg and 90mmHg≤MSDBP< 110mmHg at visit 1
- •For patients on mono antihypertensive therapy, MSSBP/MSDBP should <160/100mmHg at visit 1 (the beginning of screening period); and at visit 2(the beginning of theraputic period), they should have MSSBP≥140 mmHg and <180mmHg AND MSDBP≥90 mmHg and <110mmHg
排除标准
- •Severe hypertension
- •Malignant hypertension
- •Secondary hypertension
- •Renal dysfunction(serum creatinine > 2.0mg(176.8μmol/L)at visit 1)
- •Hepatic disease
- •History of hypertensive encephalopathy or cerebrovascular accident within 6 months
- •History of myocardial infarction, coronary revascularization within 6 months
- •Type 1 diabetes mellitus
- •patietns with HbA1c >8% at visit 1
- •Women in pregnancy and lactation
- •Potentially fertile female patients not using effective contraceptive methods
- •Be allergy to study drug.
- •Other protocol defined inclusion/exlusion criteria may apply
研究组 & 干预措施
valsartan
Experimental
After 1-week screening period, all of the eligible patients receive valsartan 80mg/day for 2 weeks, then the dosage will be titrated to 160mg/day for further 8 weeks therapy for all of the subjects.
干预措施: Valsartan (Drug)
结局指标
主要结局
Change from baseline and week 2 in blood pressure at week 10
时间窗: Baseline, 2 week and 10 weeks
次要结局
- Percentage of of patients who achieve BP<140/90mmHg(Baseline and 10 weeks)
- Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10(Baseline and 10 weeks)
- Change from baseline in HBPM (Home Blood Pressure Monitor) at week 10(Baseline and 10 weeks)
- Number of patients with adverse events, serious adverse events(during 10 weeks)
研究者
研究点 (1)
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