NCT02808026已完成3 期
A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Patients With Severe Hypertension (Grade III)
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
- 20
- 主要终点
- Change from baseline in sitting systolic and diastolic blood pressure
研究概览
简要总结
To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 20 to 80 years at informed consent
- •Subjects with severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg)
排除标准
- •Patients who are suspected hypertensive emergency
- •Secondary hypertension or malignant hypertension
- •Diabetes mellitus with albuminuria
- •Serum potassium level < 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive RA inhibitor)
- •eGFR < 60 mL/min/1.73 m^2.
研究组 & 干预措施
CS-3150
Experimental
CS-3150 2.5 to 5mg, orally, once daily after breakfast for 8 weeks
干预措施: CS-3150 (Drug)
结局指标
主要结局
Change from baseline in sitting systolic and diastolic blood pressure
时间窗: Baseline to end of Week 8
次要结局
- Proportion of patients achieving blood pressure control(Baseline to end of Week 8)
- Time course of systolic and diastolic blood pressure(Baseline to end of Week 8)
研究者
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