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A randomized, open-label study to evaluate the efficacy and safety of esaxerenone compared to angiotensin receptor blockers in older patients with hypertension

ESCORT-HT Study

Kario Kazuomi

Jichi Medical University (Jichi Medical University Hospital)

3311-1, Yakushiji, Shimotsuke City, Tochigi

kkario@jichi.ac.jp

Kario Kazuomi

Jichi Medical University

3311-1, Yakushiji, Shimotsuke City, Tochigi

+81-285-44-2111

kkario@jichi.ac.jp

Complete

Aug. 27, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

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

Both

Older patients with hypertension

[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 diabetic patients with albuminuria should start with 1.25mg of esaxerenone, and the dose is increased to 2.5 mg after 4 week of the administration period, depending on the patient's condition including serum potassium level.

[Dosage and administration of the comparator drug]
ARB is given orally once daily, according to the dosage on the electronic package insert.
ARB is given either Azilsartan, Irbesartan, Olmesartan Medoxomil, Candesartan Cilexetil, Telmisartan, Valsartan or Losartan Potassium.
If the dose is started from a low dose according to each electronic supplement, the dose should be increased to the standard dose after the 4th week of administration. The dosage may be adjusted depending on patient's age and symptoms.

[Dosage considerations]
In principle, patients started at low dose increase tothe standard dose after the 4th week of the treatment period based on the dose criteria. After increasingto the standard dose, neither reducing the dose below the standard dose nor administering the maximum dose is acceptable.

Hypertension

Change from baseline in morning home blood pressure (systolic blood pressure)

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

+81-3-3470-3360

Yes

The datasets generated and/or analyzed during the current study will be available from the corresponding author and Daiichi Sankyo.Co.,Ltd. on reasonable request.

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