EXCITE-HT study

JRCT ID: jRCTs031220372

Registered date:07/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients with essential hypertension inadequately controlled with ARB or CCB
• Date of first enrollment: 13/12/2022
• Target sample size: 540
• Study type: Interventional

Intervention(s)

[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 with moderate renal dysfunction (eGFRcreat is 30 or more and less than 60 mL.min/1,73m2) and diabetic patients with albuminuria or proteinuria 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. If the effect is insufficient, the dose can be increased to 5 mg.

[Dosage and administration of the research drug (Comparator drug)]
Trichlormethiazide is given orally, 2-8 mg per day divided into 1-2 doses. The dosage may be adjusted depending on patient's age and symptoms.
However, when used for hypertension, start with a small dose and gradually increase the dose.

Outcome(s)

• Primary Outcome: Change from baseline in morning home blood pressure (systolic and diastolic blood pressure)

Secondary Outcome

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:3.5 mEq/L or less,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

Key inclusion & exclusion criteria

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

Include 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.

Exclude 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

Related Information

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