NCT00376636已完成2 期
A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Parallel-Design, Four-Week Study to Investigate the Safety and Efficacy of the Oral Renin Inhibitor SPP635 Once Daily in Patients With Mild to Moderate Hypertension
Speedel Pharma Ltd.1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2006年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Lowering of systolic office blood pressure
研究概览
简要总结
This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension.
详细描述
Renin-Angiotensin system blockade is a well established target for treatment of high blood pressure. Blocking the system at the initial step, however, is a rather new concept that could only be implemented very recently through the availability of novel, oral, renin inhibitors. This study investigates the safety and efficacy of a novel oral renin inhibitor, SPP635.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients with mild to moderate hypertension
排除标准
- •female patients of child-bearing potential or breast-feeding
结局指标
主要结局
Lowering of systolic office blood pressure
时间窗: four weeks
Lowering of diastolic office blood pressure
时间窗: four weeks
次要结局
- Lowering of systolic and diastolic blood pressure (ABPM)(four weeks)
研究者
研究点 (1)
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