UMIN-CTR Clinical Trial

Basic information
Public title	Safety and antihypertensive effect of switching from eplerenone to esaxerenone in hypertensive patients.
Acronym	Safety and antihypertensive effect of switching from eplerenone to esaxerenone in hypertensive patients.
Scientific Title	Safety and antihypertensive effect of switching from eplerenone to esaxerenone in hypertensive patients.
Scientific Title:Acronym	Safety and antihypertensive effect of switching from eplerenone to esaxerenone in hypertensive patients.
Region	Japan

Condition
Condition	hypertensive patients
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of switching from eplerenone to esaxerenone on blood pressure, blood pressure fluctuation, and onset and progression of organ damages.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in blood pressure, pulse rate, serum levels of potassium and creatinine, and eGFR.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	esaxerenone 12 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have been administered eplerenone for more than 8 weeks.
Key exclusion criteria	Patients with heart failure. Patients who have taken potassium-sparing diuretics (spironolactone, triamterene, and potassium canrenoate) or potassium preparations during the last 8 weeks. Patients whose serum potassium level exceeded 5.0 mEq/L. Patients with severe renal dysfunction (eGFR <30 mL/min/1.73m2).
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Atsuhiro Middle name Last name Ichihara
Organization	Tokyo Women's Medical University
Division name	Department of Endocrinology and Hypertension
Zip code	162-8666
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL	+81-333538111
Email	atzichihara@twmu.ac.jp

Public contact
Name of contact person	1st name Nobukazu Middle name Last name Sasaki
Organization	Tokyo Women's Medical University
Division name	Department of Endocrinology and Hypertension
Zip code	168-8666
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL	+81-333538111
Homepage URL
Email	sasaki.nobukazu@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Women's Medical University
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo
Tel	+81-333538111
Email	inai.kiyoshi@twmu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 07 Month 25 Day
Date of IRB	2019 Year 07 Month 25 Day
Anticipated trial start date	2024 Year 05 Month 15 Day
Last follow-up date	2024 Year 08 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 19 Day
Last modified on	2022 Year 02 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042942