JPRN-jRCT2080222831已完成2 期
A Phase 2 Exploratory Study to evaluate efficacy and safety of CS-3150 in Japanese Hypertensive Patients with Moderate Kidney Dysfunction
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 33 人开始时间: 2015年4月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
The efficacy and safety of CS-3150 titrated from 1. 25 mg, 2.5 mg to 5 mg were investigated in hypertensive patients with moderate kidney dysfunction for 12 weeks. The change in sitting blood pressure was significantly decreased in both systolic and diastolic blood pressures, and the change in sitting blood pressure decreased until Week 12 of the treatment period, demonstrating the hypotensive effects of CS-3150. No notable safety concerns were identified and tolerability was confirmed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1)Male and female subjects aged 20 years or older and 80 years or younger at informed consent
- •2)Subjects with hypertension (Sitting SBP >= 140 mmHg and < 180 mmHg, Sitting DBP >= 80 mmHg and < 110 mmHg)
- •3) eGFR >= 30 mL/min/1.73 m2 and < 60 mL/min/1.73 m2
排除标准
- •1)Secondary hypertension (except renoparenchymal hypertension) or malignant hypertension
- •2)Diabetes mellitus with albuminuria
- •3)Serum potassium level < 3.5 or >= 5.1 mEq/L
- •4)Subjects under Insulin treatment
- •5)Subjects under or pre-planned for hemodialysis
研究者
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