A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 426
- 主要终点
- Change from baseline in sitting systolic and diastolic blood pressure
研究概览
简要总结
This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 (Sitting SBP ≥ 140 mmHg and < 180 mmHg, Sitting DBP ≥ 90 mmHg and < 110 mmHg,and 24h-hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)
排除标准
- •Secondary hypertension or malignant hypertension
- •Diabetes mellitus with albuminuria
- •Serum potassium level < 3.5 or ≥ 5.1 mEq/L
- •Reversed day-night life cycle including overnight workers
- •eGFR < 60 mL/min/1.73 m^2
研究组 & 干预措施
CS-3150 1.25 mg
One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
干预措施: CS-3150 (Drug)
CS-3150 1.25 mg
One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
干预措施: placebo (Drug)
CS-3150 2.5 mg
Two CS-3150 1.25 mg tablets administered orally, once daily after breakfast.
干预措施: CS-3150 (Drug)
CS-3150 5 mg
Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast.
干预措施: CS-3150 (Drug)
Placebo
Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.
干预措施: placebo (Drug)
Eplerenone, 50-100 mg (Open Label)
One or two 50mg eplerenone tablet(s) administered orally, once daily after breakfast.
干预措施: eplerenone (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 week 12
次要结局
- Change from baseline in 24-hr blood pressure (ABPM)(Baseline to end week 12)