NCT02722265已完成3 期
Open-label, Multicenter, Interventional, Dose Titration Study to Assess the Long-term Study of CS-3150 2.5mg and 5mg Alone as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
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
- 368
- 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, pharmacodynamics, and safety of long-term administration of CS-3150 as monotherapy and in combination with calcium channel blocker or renin-angiotensin system inhibitor in patients with essential hypertension.
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
- •Male and female subjects aged 20 years or older at informed consent
- •Subjects with essential hypertension, who do not receive any antihypertensive drugs or receive calcium channel blocker, angiotensin converting enzyme ACE inhibitor, or angiotensin-II receptor blockade ARB during run-in period (Sitting systolic blood pressure SBP ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP ≥ 90 mmHg and < 110 mmHg, and mean 24hr SBP ≥ 130 and DBP ≥ 80 mmHg)
排除标准
- •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 ACE inhibitor, or ARB)
- •Reversed day-night life cycle including overnight workers
- •estimated glomerular filtration rate eGFR < 60 mL/min/1.73 m^2.
研究组 & 干预措施
CS-3150
Experimental
CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 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: week 0 (baseline) to end of weeks 12, 28, and 52
次要结局
- Change from baseline in 24-hr ambulatory blood pressure monitoring (ABPM)(week 0 (baseline) to end of weeks 12, 28, and 52)
研究者
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