JPRN-jRCTs031200364已完成未知
An Exploratory Study of the Efficacy and Safety of Esaxerenone in Uncontrolled Nocturnal Hypertensive Patients : a single-arm, open-label study. - EARLY-NH study
Kario Kazuomi0 个研究点目标入组 101 人开始时间: 2021年2月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 101
研究概览
简要总结
The amount of change in nocturnal blood pressure using the brachial sphygmomanometer, which is the primary endpoint, shown a statistically significant decrease in both systolic and diastolic blood pressure. A statistically significant decrease was also shown in home blood pressure early morning and before bedtime, and in consultation room blood pressure. No serious adverse reactions were reported and no new adverse events/adverse reactions requiring confirmation were noted in the safety evaluation.
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) Patients aged 20 years or older at informed consent
- •2) Patients administered ARB or CCB
- •3) Patients with a nocturnal systolic BP of at least 120 mmHg
排除标准
- •1) Patients diagnosed with secondary hypertension or malignant hypertension
- •2) Patients with hyperkalemia or serum potassium levels exceeding 5.0 mEq/L
- •3) Patients with any cerebro-cardiovascular diseases
- •4) Patients who used prohibited concomitant medications
- •5) Patients with severely impaired renal function (eGFRcreat < 30 mL/min/1.73 square meter)
- •6) Patients with seriously impaired hepatic function (e.g., hepatic failure and hepatic cirrhosis)
- •7) Patients with a life expectancy within 1 year due to some disease
- •8) Patients with a history of serious drug allergies
- •9) Pregnant, possibly pregnant, breast-feeding or planning to become pregnant
- •10) Patients working the night shift at least 3 days a week in a shift-work system
- •11) Patients deemed otherwise unsuitable for the study by the investigator
研究者
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