NCT00171405已完成3 期
A 4 Month Extension to 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
- 250
- 试验地点
- 10
- 主要终点
- Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study
研究概览
简要总结
The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.
- •absence of ongoing severe adverse events at Visit 10.
排除标准
- 未提供
结局指标
主要结局
Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study
次要结局
- Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months
- Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months
- Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months
- Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline
- Blood pressure less than 140/90 mmHg
研究者
研究点 (10)
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