A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,001
- 主要终点
- Change from baseline in sitting blood pressure
研究概览
简要总结
To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.
详细描述
Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension.
Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.
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 satisfying the following blood pressure criteria;
- •Sitting SBP: ≥ 140 mmHg and < 180 mmHg
- •Sitting DBP: ≥ 90 mmHg and < 110 mmHg
- •Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg
排除标准
- •Secondary hypertension or malignant hypertension
- •Diabetic nephropathy or 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 2.5 mg
CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks
干预措施: CS-3150 (Drug)
CS-3150 5.0 mg
CS-3150 5 mg, orally, once daily after breakfast for 12 weeks
干预措施: CS-3150 (Drug)
Eplerenone
Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks
干预措施: Eplerenone (Drug)
结局指标
主要结局
Change from baseline in sitting blood pressure
时间窗: Baseline to end of Week 12
Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP).
次要结局
- Change from baseline in 24 hour average blood pressure(Baseline to end of Week 12)