NCT00246584已完成2 期
Long-Term Treatment, Multicenter, Open-Label Study With SPP100 in Patients With Essential Hypertension
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of adverse events, vital signs, abnormal laboratory changes,etc.
研究概览
简要总结
This study will evaluate the safety and efficacy of long term treatment of SPP100 in patients with essential hypertension. (Trial is not recruiting in the US)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Diagnosed as essential hypertension -
排除标准
- •Patients with secondary hypertension or suspected of having secondary hypertension.
- •Patients suspected of having malignant hypertension
- •Patients with any serious diseases or symptoms
结局指标
主要结局
Incidence of adverse events, vital signs, abnormal laboratory changes,etc.
次要结局
- Change from baseline in diastolic blood pressure after 52 weeks
- Change from baseline in systolic blood pressure after 52 weeks
- Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks
研究者
研究点 (1)
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