JPRN-jRCT2080223294已完成3 期
A Study of CS-3150 to Evaluate Efficacy and Safety in Patients with Primary Aldosteronism
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
研究概览
简要总结
The efficacy and safety of CS-3150 2.5mg administered once daily until 5 mg f was evaluated in patients with primary aldosteronism or 12 weeks. In the evaluation of the change in sitting blood pressure, the blood pressure value at the end of treatment significantly decreased both systolic and diastolic blood pressure compared with the baseline blood pressure value in the run-in period. No safety issues were observed.
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) Patients diagnosed primary aldosteronism by screening test of PAC and ARR, and confirmatory testing
- •3) Patients satisfying following blood pressure;
- •i)-sitting SBP >= 140 mmHg and <180 mmHg
- •-sitting DBP >= 90 mmHg and <110 mmHg,
- •ii) between two measurement difference =<30/15 mmHg)
排除标准
- •1)Secondary hypertension except primary aldosteronism or hypertensive emergency
- •2)Patients diagnosed diabetic nephropathy
- •3)Patients with type 1 diabetes
- •4)eGFR < 30 mL/min/1.73m2
- •5)Serum potassium level < 3.0 or >= 5.1 mEq/
研究者
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