JPRN-jRCT2080222720已完成2 期
A Phase 2 Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 426 人开始时间: 2015年1月16日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 426
研究概览
简要总结
Sitting blood pressure, the primary endpoint, decreased dose-dependently with CS-3150, demonstrating the superiority of antihypertensive efficacy over placebo in the CS-3150 2.5 mg and 5 mg groups. The incidence of adverse events did not tend to increase in any treatment group.
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 (Sitting SBP >= 140 mmHg and < 180 mmHg, Sitting DBP >= 90 mmHg and < 110 mmHg, and 24hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)
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)Reversed day-night life cycle including overnight workers
- •5)eGFR < 60 mL/min/1.73 m^2
研究者
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