UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037722 |
|---|---|
| Receipt number | R000042942 |
| Scientific Title | Safety and antihypertensive effect of switching from eplerenone to esaxerenone in hypertensive patients. |
| Date of disclosure of the study information | 2019/08/19 |
| Last modified on | 2022/02/21 16:18:47 |
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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
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
sasaki.nobukazu@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042942
