NCT01237873已完成3 期
A Open-label, 52 Week, Extension to an 8-week, Double Blind, Multicenter, 6-arm, Placebo-controlled, Parallel Group Study to Evaluate the Long Term Safety of SPA100 (Aliskiren/Amlodipine)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that complete CSPA100A1301 study
- •Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled
排除标准
- •Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study
- •Presence of major protocol violation in CSPA100A1301 study
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Ali/Amlo
Experimental
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
干预措施: Ali/Amlo 150/2.5 mg (Drug)
结局指标
主要结局
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
时间窗: 52 weeks
Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.
次要结局
- Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.(52 weeks)
- The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study(52 weeks)
研究者
研究点 (1)
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