JPRN-jRCT2080223293已完成3 期
A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN study)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,001
研究概览
简要总结
CS-3150 was administrated once daily for 12 weeks to patients with essential hypertension. The change in sitting blood pressure as the primary efficacy endpoint, was evaluated. The non-inferiority of CS-3150 2.5 mg to eplerenone 50 mg was verified, and the antihypertensive effect of CS-3150 5 mg was statistically significantly superior to that of 2. 5 mg. The incidence of adverse events was similar between 2.5 mg and 5 mg of CS-3150 and 50-mg of eplerenone.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Male and female subjects aged 20 years or older at informed consent
- •2) Subjects with essential hypertension and satisfied the following blood pressure criteria during run-in period;
- •-Sitting BP: SBP >= 140 mmHg and < 180 mmHg, DBP >= 90 mmHg and < 110 mmHg
- •-Mean 24 hr BP: SBP >= 130 and DBP >= 80 mmHg
排除标准
- •1)Secondary hypertension or malignant hypertension
- •2)Diabetic nephropathy or diabetes mellitus with albuminuria
- •3)Serum potassium level < 3.5 or >= 5.1 mEq/L
- •4)Reversed day-night life cycle including overnight workers
- •5)eGFR < 60 mL/min/1.73 m^2.
研究者
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