NCT00219167已完成3 期
An 8-week, Randomized, Double-blind, Parallel-group, Multicenter Study Assessing the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Patients With at Least 65 Years of Age With Essential Hypertension, Using 24-hour ABPM, With Lisinopril 10 mg as a Reference
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
- 355
- 试验地点
- 1
- 主要终点
- Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks
研究概览
简要总结
After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg for a period of 8 weeks
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least 65 years-old
- •Patients with essential hypertension
排除标准
- •Severe hypertension
- •History or evidence of a secondary form of hypertension
- •History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.
结局指标
主要结局
Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks
次要结局
- Change from baseline in daytime systolic ambulatory blood pressure after 8 weeks
- Change from baseline in sitting systolic and diastolic blood pressure after 8 weeks
- Change from baseline in daytime diastolic ambulatory blood pressure after 8 weeks
- Blood pressure control target of < 140/90 mmHg after 8 weeks
- Change from baseline in average 24 hour diastolic ambulatory blood pressure after 8 weeks
研究者
研究点 (1)
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