UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010673 |
|---|---|
| Receipt number | R000012451 |
| Scientific Title | Effects of long-term treatment with mineralocorticoid receptor antagonists on aldosterone synthesis in patients with primary aldosteronism |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2015/11/09 08:01:21 |
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Basic information
Public title
Effects of long-term treatment with mineralocorticoid receptor antagonists on aldosterone synthesis in patients with primary aldosteronism
Acronym
Effects of mineralcorticoid receptor antagonists on aldosterone synthesis
Scientific Title
Effects of long-term treatment with mineralocorticoid receptor antagonists on aldosterone synthesis in patients with primary aldosteronism
Scientific Title:Acronym
Effects of mineralcorticoid receptor antagonists on aldosterone synthesis
Region
| Japan |
Condition
Condition
Primary aldosteronism
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of long-term treatment with mineralocorticoid receptor antagonists on aldosterone synthesis in patients with primary aldosteronism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma aldosterone concentration
Key secondary outcomes
Blood pressure
Base
Study type
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
Estimation of aldosterone synthesis after withdrawal of mineralocorticoid receptor anagonists.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with primary aldosteronism treated with mineralocorticoid receptor antagonists for 1 year.
Key exclusion criteria
patients with uncontrolled blood pressure treated with mineralocorticoid receptor alone.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyu Takeda |
Organization
Kanazawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa-Ken 920-8690, Japan,
TEL
076-265-2252
takeday@maed.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Yoneda |
Organization
Kanazawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
13-1 takara-machi, Kanazawa, Japan
TEL
076-265-2252
Homepage URL
endocrin@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Graduate School of Medical Science, Kanazawa University, Kanazawa, Japan
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
金沢大学付属病院(石川県), 芳珠記念病院(石川県),高岡市民病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 01 | 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
| 2013 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 08 | Day |
Last modified on
| 2015 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012451
