JPRN-jRCT2080221876已完成2 期
Phase 2 Study to Evaluate Efficacy and Safety of CS-3150 in Patients with Essential Hypertension
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 164 人开始时间: 2012年8月7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
- 164
研究概览
简要总结
In the CS-3150 group, the mean change from baseline and end-of-treatment blood pressure values in sitting blood pressure and 24-hour blood pressure were greater with increasing dose, and the pharmacodynamic endpoints in the blood were roughly greater with increasing dose. Regarding safety, there were no serious adverse events, severe adverse events, or adverse events leading to study discontinuation.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •Main Inclusion Criteria;
- •- Sitting blood pressure:stable, mean systolic BP>=140 and <180 mmHg, and mean diastolic BP>=90 and <110 mmHg.
- •- 24-hour mean BP by ambulatory blood pressure monitoring (ABPM) : systolic BP >- 130 mmHg, and diastolic BP >-80 mm Hg.
排除标准
- •1) Secondary hypertension or malignant hypertension
- •2) Subjects with diabetes or with treatment for diabetes
- •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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