Nocturnal hypertension
Conditions
Interventions
According to the package insert, esaxerenone is administered orally once a day. Esaxerenone will be started at 2.5 mg and can be titrated up to 5 mg if response is not adequate. In patients with moder
Sponsors
Kario Kazuomi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 20 years or older at informed consent 2) Patients administered ARB or CCB 3) Patients with a nocturnal systolic BP of at least 120 mmHg
Exclusion criteria
Exclusion criteria: 1) Patients diagnosed with secondary hypertension or malignant hypertension 2) Patients with hyperkalemia or serum potassium levels exceeding 5.0 mEq/L 3) Patients with any cerebro-cardiovascular diseases 4) Patients who used prohibited concomitant medications 5) Patients with severely impaired renal function (eGFRcreat < 30 mL/min/1.73 square meter) 6) Patients with seriously impaired hepatic function (e.g., hepatic failure and hepatic cirrhosis) 7) Patients with a life expectancy within 1 year due to some disease 8) Patients with a history of serious drug allergies 9) Pregnant, possibly pregnant, breast-feeding or planning to become pregnant 10) Patients working the night shift at least 3 days a week in a shift-work system 11) Patients deemed otherwise unsuitable for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Evaluation Change from baseline in nocturnal BP (systolic BP and diastolic BP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Evaluation 1) Change from baseline in sitting BP (office BP and home BP before early morning medication and bedtime: systolic BP and diastolic BP) 2) Change from baseline in nocturnal BP (systolic BP and diastolic BP) measured with a home wrist BP monitor 3) Time courses of sitting BP and nocturnal BP 4) Achievement ratio of target BP level for sitting BP and nocturnal BP at Week 12 5) Change from baseline in urinary albumin/creatinine ratio 6) Change from baseline in NT-proBNP and normalization rate (= 5.5 mEq/L => 6.0 mEq/L 4) Time course of serum potassium level 5) Time course in pulse rate and change from baseline in pulse rate | — |
Contacts
Public ContactSatoshi Hoshide
Jichi Medical University Hospital
Outcome results
None listed