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

Kario Kazuomi0 个研究点目标入组 540 人开始时间: 2022年10月7日最近更新: 2023年10月17日

适应症

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•Patients will be included if they meet all of the following inclusion criteria:
•1) Patients (=> 20 year of age) at the time of informed consent
•2) Hypertensive patients treated with an antihypertensive drug (ARB or CCB) *1
•3) 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:
•1) Patients diagnosed with secondary hypertension (endocrine hypertension, etc.)
•2) Hyperkalemia patients or patients with serum potassium level over 5.0 mEq/L
•3) Patients with hyponatremia or hypokalemia
•4) Patients with severe renal impairment (eGFRcreat< 30 mL/min/1.73m2)
•5) Patients with acute renal failure or anuria
•6) Patients with a history of hypersensitivity to esaxerenone or thiazide diuretics
•7) Pregnant, possibly pregnant, breast-feeding or planning to become pregnant
•8) Patients who are inappropriate for this study judged by primary investigators

发起方

Kario Kazuomi