NCT00311012已完成2 期
Dose-finding Study of SPP100 in 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
- 445
- 试验地点
- 1
- 主要终点
- Change from baseline in mean sitting diastolic blood pressure after 8 weeks
研究概览
简要总结
This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate essential hypertension
- •Age: ≥20 years old and <80 years old (at time informed consent obtained)
- •Admission status: Outpatient
排除标准
- •Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant
- •Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3
- •Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension
- •Patients suspected of having malignant hypertension
结局指标
主要结局
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
次要结局
- Change from baseline in mean sitting systolic blood pressure after 8 weeks
- Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline after 8 weeks
- Evaluate response to various doses by assessing the difference in mean sitting diastolic blood pressure after 8 weeks
研究者
研究点 (1)
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