NCT00299832已完成3 期
A Multi-center, Open-label Study Assessing the Safety, Efficacy and Pharmacokinetics of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
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
- 40
- 试验地点
- 1
- 主要终点
- Adverse events after 8 weeks
研究概览
简要总结
Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction
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
- •Elevated Serum Creatinine
排除标准
- •Patients suspected of malignant hypertension
- •Patients with a clinically significant allergy
- •Patients who have received other investigational drug Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Adverse events after 8 weeks
次要结局
- Change from baseline in mean sitting systolic blood pressure after 8 weeks
- Change from baseline in mean sitting diastolic blood pressure after 8 weeks
- Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
- Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks
- Blood pressure <140/90 after 8 weeks
研究者
研究点 (1)
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