UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017956 |
|---|---|
| Receipt number | R000020811 |
| Scientific Title | Usefulness of adrenal vein sampling and surgery on unilateral primary aldsteronism |
| Date of disclosure of the study information | 2015/06/18 |
| Last modified on | 2018/12/20 12:11:17 |
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Basic information
Public title
Usefulness of adrenal vein sampling and surgery on unilateral primary aldsteronism
Acronym
Usefulness of adrenal vein sampling and surgery on unilateral primary aldsteronism
Scientific Title
Usefulness of adrenal vein sampling and surgery on unilateral primary aldsteronism
Scientific Title:Acronym
Usefulness of adrenal vein sampling and surgery on unilateral primary aldsteronism
Region
| Japan |
Condition
Condition
primary aldsteronism
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Usefulness of adrenal vein sampling and surgery on unilateral primary aldsteronism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
resoult of adrenal vein ampling, and plasma renin activity and plasma aldsterone concentration
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
Prevention
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
adrenal vein sampling and medication for adrenal vein sampling
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
primary aldsteronism 20 years of age and older who take account for surgery
Key exclusion criteria
inoperable, unwanted to be operated, allergy of contrast dye, aged, impaired renal function
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhito Azuma |
Organization
Osaka Medical College
Division name
Urology
Zip code
Address
2-7 Daigakumachi Takatsuki city Osaka Japan
TEL
072-683-1221
uro004@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Tsujino |
Organization
Osaka Medical College
Division name
Urology
Zip code
Address
2-7 Daigakumachi Takatsuki city Osaka Japan
TEL
072-683-1221
Homepage URL
uro061@osaka-med.ac.jp
Sponsor or person
Institute
Urology of Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Urology of Osaka Medical College
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 18 | Day |
Last modified on
| 2018 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020811
