EARLY-NH study

JRCT ID: jRCTs031200364

Registered date:15/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Nocturnal hypertension
• Date of first enrollment: 22/04/2021
• Target sample size: 100
• Study type: Interventional
• Intervention(s): 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 moderately impaired renal function (eGFRcreat of => 30 to < 60 mL/min/1.73 square meter) or diagnosed with albuminuria or proteinuria associated with diabetes mellitus, esaxerenone will be started at 1.25 mg and will generally be titrated up to 2.5 mg after 4 weeks of treatment, depending on the condition of the subject (e.g., serum potassium level). If there is an inadequate response, esaxerenone can be titrated up to 5 mg.

Outcome(s)

Primary Outcome

Efficacy Evaluation
Change from baseline in nocturnal BP (systolic BP and diastolic BP)

Secondary Outcome

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 (=<55 pg/mL) in serum NT-proBNP
7) Change from baseline in vascular function evaluation (CAVI)
8) Change from baseline in plasma renin activity and aldosterone concentration
9) Change from baseline in urinary biomarkers (Na, K, Cr)
Safety Evaluation
1) Incidence of adverse events
2) Time course in eGFRcreat and change from baseline in eGFRcreat
3) Proportion of subjects with the following serum potassium levels
=> 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kario Kazuomi
• Source(s) of Monetary Support: Daiichi Sankyo.Co., Ltd.