NCT00219037已完成3 期
A 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long Term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential 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
- 1,955
- 试验地点
- 1
- 主要终点
- Adverse events, laboratory abnormalities, serious adverse events
研究概览
简要总结
Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.
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
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with essential hypertension.
- •Patients who are eligible and able to participate in the study.
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 exclusion criteria may apply.
结局指标
主要结局
Adverse events, laboratory abnormalities, serious adverse events
次要结局
- Change from baseline in mean sitting diastolic blood pressure after 12 months
- Change from baseline in mean sitting systolic blood pressure after 12 months
- Change from baseline in standing systolic blood and diastolic pressure after 12 months
- Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline
- Blood pressure less than 140/90 mmHg
研究者
研究点 (1)
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