NCT01241487已完成4 期
An 8 Weeks Open Label National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10)
研究概览
简要总结
This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient uncontrolled by mono-therapy for at least 8 weeks, having B.P.>/= 140/90 mmHg in non diabetics or >/= 130/80 mmHg in diabetics
排除标准
- •Patient having B.P.>= 180/110 mmHg in non diabetics or >= 160/100 mmHg in diabetics
- •Type 1 Diabetes or uncontrolled type 2 Diabetes.
- •PCI in last 12 months.
- •Concomitant unstable angina. Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
valsartan/amlodipine
干预措施: valsartan/amlodipine (Drug)
结局指标
主要结局
Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10)
时间窗: 4 weeks
次要结局
- The incidence of Edema(8 weeks)
- Hypertension of patients that were previously controlled on (160/5) and those that were uncontrolled and switched to the higher concentration (160/10) after 4 weeks on (160/5) concentration.(8 weeks)
- Safety and Tolerability of the Trial Medication(8 weeks)
研究者
研究点 (1)
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