NCT00299806已完成3 期
A Multi-center, Open-label Study Assessing the Safety and Efficacy of 8 Week's Treatment of SPP100 (Aliskiren) Regimen 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
- 39
- 试验地点
- 1
- 主要终点
- Incidence of adverse events after 8 weeks
研究概览
简要总结
Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20 - 80 years old
- •Gender: Male or female
- •Status: Outpatients
- •severe hypertension
排除标准
- •Patients with a clinically significant allergy
- •Patients who have received other investigational drug
- •Alcoholic patients
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Incidence of adverse events after 8 weeks
次要结局
- Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks
- Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks.
- Average sitting systolic blood pressure/mean sitting diastolic blood is < 160/100 mmHg or blood pressure reduction from baseline is > 20/10 mmHg after 8 weeks
研究者
研究点 (1)
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