jRCTs031240300进行中（未招募）不适用
A randomized, open-label study to evaluate the efficacy and safety of esaxerenone compared to angiotensin receptor blockers in older patients with hypertension
未提供0 个研究点目标入组 380 人开始时间: 2024年9月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 380
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 65age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients will be included if they meet all of the following inclusion criteria:
- •Patients (=> 65 year of age) at the time of informed consent
- •Hypertensive patients treated with Amlodipine Besilate 2.5 mg or 5 mg for at least 4 weeks before the start of the observation period
- •Patients with mean systolic blood pressure =>135 mmHg in the last 5 days of early morning home blood pressure measured by a brachial sphygmomanometer.
排除标准
- •Patients who meet any of the following criteria will be excluded:
- •Patients diagnosed with secondary hypertension (endocrine hypertension, etc.)
- •Hyperkalemia patients
- •Patients with serum potassium level over 4.8 mEq/L
- •Patients with eGFRcreat less than 45 mL/min/1.73m2
- •Patients with extremely poor bile secretion or severe liver impairment
- •Patients with a history of clinically significant adverse reactions to esaxerenone or ARB
- •Pregnant, possibly pregnant or planning to become pregnant
- •Patients who are inappropriate for this study judged by primary investigators
结局指标
主要结局
-
Change from baseline in morning home blood pressure (systolic blood pressure)
次要结局
- Change from baseline in morning home, bedtime home and office blood pressure (systolic and diastolic blood pressure)
- Changes in each blood pressure (morning home, bedtime home and office(systolic and diastolic blood pressure))
- Achieving rate of target blood pressure (morning home, bedtime home and office)
- Change,%change from baseline and change from baseline in UACR
- Change and %change in NT-proBNP
- Change from baseline in PAC, PRA and ARR
- Changes and change from baseline in urinary biomarkers (Na,K, Na/K and Cr)
- Adverse events (event name, number of events and incidence rate)
- Change and Change from baseline in serum potassium levels, serum sodium level and eGFRcreat
- Change from baseline in laboratory test values(HbA1c)
- Percentage of study subjects with serum potassium levels: 5.5 mEq/L or moreand 6.0 mEq/L or more
- Percentage of study subjects with serum sodium level : less than 135.0 mEq/L
- Pulse rate
研究者
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