NCT00273299已完成3 期
A 6-Week Study to Evaluate the Combination of Valsartan/HCTZ (160/12.5mg With Forced Titration to Maximum Dose of 320/25mg) Compared to Valsartan Monotherapy (160mg With Forced Titration to 320mg) as Initial Therapy in Patients With Severe Hypertension
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
- 607
- 试验地点
- 2
- 主要终点
- Blood pressure less than 140/90 mmHg after 4 weeks
研究概览
简要总结
The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.
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
- Double
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
- •Diagnosed severe hypertension
排除标准
- •Inability to discontinue all prior antihypertensive medications
- •Heart failure of any kind
- •History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease
- •Diabetes with poor glucose control
- •Allergy to certain medications used to treat high blood pressure
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Blood pressure less than 140/90 mmHg after 4 weeks
次要结局
- Blood pressure less than 140/90 mmHg after 6 weeks
- Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks
- Systolic blood pressure less than 140 mmHg after 4 and 6 weeks
- Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks
- Adverse events and serious adverse events at each study visit for 6 weeks
研究者
研究点 (2)
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