NCT00311740已完成3 期
A Multi-center, Factorial Study to Evaluate Efficacy & Safety of 8 Wks Treatment With VAH631 [Valsartan (40 & 80 mg) and Hydrochlorothiazide (6.25 & 12.5 mg) Combined & Alone in Essential Hypertensive Patients] - Double-blind Study of VAH631 in Patients With Essential Hypertension (Factorial Study)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 582
- 试验地点
- 1
- 主要终点
- Change from baseline in diastolic blood pressure after 8 weeks
研究概览
简要总结
The purpose of this study is to compare the effect of the fixed combination of valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ alone and whether the combination treatments are safe and well tolerated. The study aims to establish a dose response relationship for both monotherapies and the combinations.
This study is being conducted in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
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
- •Essential hypertension measured by mercury sphygmomanometer
- •Outpatients
排除标准
- •Secondary hypertension or suspected of having secondary hypertension.
- •A history of malignant hypertension
- •Severe hypertension
- •Significant heart, renal, hepatic diseases or significant cerebrovascular disorder
- •Gout Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Change from baseline in diastolic blood pressure after 8 weeks
次要结局
- Adverse events and serious adverse events at each study visit for 8 weeks
- Change from baseline in systolic blood pressure after 8 weeks
- Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks
- Change from baseline in standing diastolic blood pressure after 8 weeks
- Change from baseline in standing systolic blood pressure after 8 weeks
研究者
研究点 (1)
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