EXCITE-HT study

Not Applicable

• Conditions: Patients with essential hypertension inadequately controlled with ARB or CCB; Hypertension

• Registration Number: JPRN-jRCTs031220372
• Lead Sponsor: Kario Kazuomi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 540

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in morning home blood pressure (systolic and diastolic blood pressure)

Secondary Outcome Measures

Name	Time	Method
1.Efficacy<br>1) Change from baseline in office blood pressure and bedtime home blood pressure (systolic and diastolic blood pressure)<br>2) Changes in each blood pressure (office, morning home and bedtime home(systolic and diastolic blood pressure))<br>3) Achieving rate of target blood pressure (office, morning home and bedtime home(systolic and diastolic blood pressure))<br>4) Change, %change from baseline and change from baseline in UACR<br>5) Change and change from baseline in urinary biomarkers (Na,K,Cr and Na/K)<br><br>2.Safety<br>1) Adverse events (event name, number of events and incidence rate)<br>2) Change and Change from baseline in eGFRcreat,uric acid and blood electrolytes (Na,K,Ca,and Cl)<br>3) Change in laboratory test values(HbA1c,blood glucose,triglycerides,T-Cho,LDL-C and HDL-C)<br>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<br>5) Percentage of study subjects with uric acid level:exceeds 7.0mg/d