JPRN-jRCT2080223121已完成3 期
A Long-term Study of CS-3150 as monotherapy or in combination with other antihypertensive drug in Japanese Patients with Essential Hypertension
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 368
研究概览
简要总结
CS-3150 was administered to patients with essential hypertension for Week 28 or Week 52. There were no safety issue, regardless of the concomitant use of antihypertensive drugs, and a stable antihypertensive effect was 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) Subjects with essential hypertension, who do not receive any antihypertensive drugs or receive calcium channel blocker, ACE inhibitor, or ARB during run-in period (Sitting SBP >= 140 mmHg and < 180 mmHg, Sitting DBP >= 90 mmHg and < 110 mmHg, and mean 24hr SBP >= 130 and DBP >= 80 mmHg)
排除标准
- •1)Secondary hypertension or malignant hypertension
- •2)Diabetes mellitus with albuminuria
- •3)Serum potassium level < 3.5 or >= 5.1 mEq/L (>= 4.8 mEq/L if receive ACE inhibitor, or ARB)
- •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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