Patients with essential hypertension inadequately controlled with ARB or CCB Hypertension
Conditions
Interventions
[Dosage and administration of the research drug]
Esaxerenone is given orally once daily. The initial daily doses will be started at 2.5 mg and titrated to 5 mg if the effect is insufficient.
Patients
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 (=> 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.
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in morning home blood pressure (systolic and diastolic blood pressure) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Efficacy 1) Change from baseline in office blood pressure and bedtime home blood pressure (systolic and diastolic blood pressure) 2) Changes in each blood pressure (office, morning home and bedtime home(systolic and diastolic blood pressure)) 3) Achieving rate of target blood pressure (office, morning home and bedtime home(systolic and diastolic blood pressure)) 4) Change, %change from baseline and change from baseline in UACR 5) Change and change from baseline in urinary biomarkers (Na,K,Cr and Na/K) 2.Safety 1) Adverse events (event name, number of events and incidence rate) 2) Change and Change from baseline in eGFRcreat,uric acid and blood electrolytes (Na,K,Ca,and Cl) 3) Change in laboratory test values(HbA1c,blood glucose,triglycerides,T-Cho,LDL-C and HDL-C) 4) Percentage of study subjects with serum potassium levels:less than 3.5 mEq/L ,5.5 mEq/L or more,6.0 mEq/L or more 5) Percentage of study subjects with uric acid level:exceeds 7.0mg/dL | — |
Contacts
Public ContactKazuomi Kario
Jichi Medical University
Outcome results
None listed