JPRN-jRCTs031210273已完成未知
An exploratory study to assess the antihypertensive effect of Esaxerenone in hypertensive patients, and its correlation with Urinary Na / K ratio or salt intake.
Katsuya Tomohiro0 个研究点目标入组 126 人开始时间: 2021年8月25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
- 126
研究概览
简要总结
Esaxerenone significantly reduced morning home BP as well as bedtime home and office BP, and also significantly decreased NT-proBNP and UACR in patients with essential hypertension inadequately controlled with an ARB or a CCB. These effects were consistent regardless of concomitant use of antihypertensive drugs (ARB and CCB) and were achieved without clinically relevant serum potassium elevation or any new safety concerns.
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
- •Patients will be included if they meet all of the following inclusion criteria:
- •1) Patients aged 20 years or older at informed consent
- •2) Hypertensive patients treated with an antihypertensive drug (ARB or CCB) at regular dose for at least 4 weeks prior to the first day of Esaxerenone treatment
- •3) Patients with a mean systolic blood pressure =>125 mmHg and/or diastolic blood pressure =>75 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.
- •1) Patients diagnosed with secondary hypertension (endocrine hypertension, hypertension due to single kidney, etc.)
- •2) Hyperkalemia patients or patients whose serum potassium level exceeds 5.0 mEq/L
- •3) Patients with severe renal impairment (eGFR< 30 mL/min/1.73m2).
- •4) Patients with severe liver dysfunction (liver failure, cirrhosis, etc.)
- •5) Patients hospitalized for myocardial infarction/heart failure, underwent percutaneous coronary angioplasty/coronary artery bypass surgery, and developed cerebral infarction/cerebral hemorrhage/subarachnoid hemorrhage/transient ischemic attack within 12 weeks before obtaining informed consent.
- •6) Patients diagnosed with life expectancy within one year due to some diseases
- •7) Patients diagnosed with dementia
- •8) Pregnant, possibly pregnant, breast-feeding or planning to become pregnant
- •9) Patients who are inappropriate for this study judged by their primary physicians
研究者
相似试验
已完成
4 期
Japan Morning Surge-1 StudyHypertensionNCT00285519Japan Heart Foundation600
已完成
不适用
ESES-LVH studyJPRN-jRCTs071190043Tsujita Kenichi60
已完成
2 期
Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart FailureHeart FailureNCT00923156Novartis Pharmaceuticals123
已完成
4 期
Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 HypertensionHypertensionNCT00853957Novartis443
终止
3 期
PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease)Type 1 DiabetesNCT00729365Northwestern University65
