A randomized, open-label study to evaluate the efficacy and safety of esaxerenone compared to trichlormethiazide in patients with essential hypertension.

未提供0 个研究点目标入组 540 人开始时间: 2022年12月13日最近更新: 2024年11月1日

试验速览

暂无简介。

•Patients will be included if they meet all of the following inclusion criteria:
•Patients (=> 20 year of age) at the time of informed consent
•Hypertensive patients treated with an antihypertensive drug (ARB or CCB) *1
•Patients with a mean systolic blood pressure =>125 mmHg and/or diastolic blood pressure =>75mmHg in the last 5 days of early morning home blood pressure measured by a brachial phygmomanometer.
•However, elderly people aged 75 years or older*2, patients with cerebrovascular disease, and patients with CKD (proteinuria negative) can be registered with systolic blood pressure =>135 mm Hg and/or diastolic blood pressure =>85 mm Hg.
•1:In principle, hypertensive patients who are taking an antihypertensive drug (ARB or CCB) for at least 4 weeks prior to the start of the observation period are eligible.
•2: if tolerated, registration with criteria of systolic blood pressure greater than 125 mmHg and/or diastolic blood pressure greater than 75 mmHg is acceptable.

•Patients who meet any of the following criteria will be excluded:
•Patients diagnosed with secondary hypertension (endocrine hypertension, etc.)
•Hyperkalemia patients or patients with serum potassium level over 5.0 mEq/L
•Patients with hyponatremia or hypokalemia
•Patients with severe renal impairment (eGFRcreat< 30 mL/min/1.73m2)
•Patients with acute renal failure or anuria
•Patients with a history of hypersensitivity to esaxerenone or thiazide diuretics
•Pregnant, possibly pregnant, breast-feeding or planning to become pregnant
•Patients who are inappropriate for this study judged by primary investigators

Change from baseline in morning home blood pressure (systolic and diastolic blood pressure)

发起方

未提供