Older patients with hypertension Hypertension
Conditions
Interventions
[Dosage and administration of the research drug]
Esaxerenone is given orally at 2.5 mg once daily.
Patients with moderate renal dysfunction (eGFRcreat is 30 or more and less than 60 mL/min/1,73m2) and
Sponsors
Kario Kazuomi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be included if they meet all of the following inclusion criteria: 1)Patients (=> 65 year of age) at the time of informed consent 2)Hypertensive patients treated with Amlodipine Besilate 2.5 mg or 5 mg for at least 4 weeks before the start of the observation period 3) Patients with mean systolic blood pressure =>135 mmHg in the last 5 days of early morning home blood pressure measured by a brachial sphygmomanometer.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded: 1)Patients diagnosed with secondary hypertension (endocrine hypertension, etc.) 2)Hyperkalemia patients 3)Patients with serum potassium level over 4.8 mEq/L 4)Patients with eGFRcreat less than 45 mL/min/1.73m2 5)Patients with extremely poor bile secretion or severe liver impairment 6)Patients with a history of clinically significant adverse reactions to esaxerenone or ARB 7)Pregnant, possibly pregnant or planning to become pregnant 8)Patients who are inappropriate for this study judged by primary investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in morning home blood pressure (systolic blood pressure) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Efficacy 1) Change from baseline in morning home, bedtime home and office blood pressure (systolic and diastolic blood pressure) 2) Changes in each blood pressure (morning home ,bedtime home and office(systolic and diastolic blood pressure)) 3) Achieving rate of target blood pressure (morning home, bedtime home and office) 4) Change,%change from baseline and change from baseline in UACR 5) Change and %change in NT-proBNP 6) Change from baseline in PAC, PRA and ARR 7) Changes and change from baseline in urinary biomarkers (Na,K, Na/K and Cr) 2.Safety 1) Adverse events (event name, number of events and incidence rate) 2) Change and Change from baseline in serum potassium levels, serum sodium level and eGFRcreat 3) Change from baseline in laboratory test values(HbA1c) 4) Percentage of study subjects with serum potassium levels: 5.5 mEq/L or moreand 6.0 mEq/L or more 5) Percentage of study subjects with serum sodium level : less than 135.0 mEq/L 6) Pulse rate | — |
Contacts
Public ContactKazuomi Kario
Jichi Medical University
Outcome results
None listed