UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037657 |
|---|---|
| Receipt number | R000042940 |
| Scientific Title | Effects of mineralocorticoid receptor antagonists on sex hormones and body composition in patients with primary aldosteronism |
| Date of disclosure of the study information | 2019/08/10 |
| Last modified on | 2024/02/16 11:37:09 |
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Basic information
Public title
Effects of mineralocorticoid receptor antagonists on sex hormones and body composition in patients with primary aldosteronism
Acronym
Effects of mineralocorticoid receptor antagonists on sex hormones and body composition in patients with primary aldosteronism
Scientific Title
Effects of mineralocorticoid receptor antagonists on sex hormones and body composition in patients with primary aldosteronism
Scientific Title:Acronym
Effects of mineralocorticoid receptor antagonists on sex hormones and body composition in patients with primary aldosteronism
Region
| Japan |
Condition
Condition
Primary aldosteronism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate body composition changes caused by mineralocorticoid antagonists and to select internal medicines
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in muscle mass before and after treatment with spironolactone and esaxerenone
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
spironolactone
Interventions/Control_2
esaxerenone
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 diagnosed with primary aldosteronism and wished to receive medication
Key exclusion criteria
Patients with secondary hypertension (endocrine hypertension, renovascular hypertension) without primary aldosteronism
Patients with essential hypertension
Subclinical Cushing syndrome patients
Patients with moderate or more impaired renal function (eGFR <30 mL / min / 1.73m2)
Diabetic patients with microalbuminuria or proteinuria
Serum K value 5.0 mEq / L or more
Pituitary hypofunction / hypogonadism patients
Patients who have taken MR antagonists in recent 8 weeks
Patients with embedded metal parts such as pacemakers
Momentum (AES) 1800 METs min / week or more
Other patients who are deemed inappropriate by the study director
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Ichihara |
Organization
Tokyo Women's Medical University Hospital
Division name
department of endocrinology and hypertension
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Education and Research Building 2nd floor
TEL
03-3353-8111
atzichihara@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Ishikawa |
Organization
Tokyo Women's Medical University Hospital
Division name
department of endocrinology and hypertension
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Education and Research Building 2nd floor
TEL
03-3353-8111
Homepage URL
ishikawa.toru@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University Hospital
Organization
Division
Category of Funding Organization
Other
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 Hospital
Address
8-1 Kawada-cho, Shinjuku-ku
Tel
03-3353-8111
ishikawa.toru@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 | 10 | 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
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | 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 | 10 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042940
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
