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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017956
Receipt No. 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

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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
Email 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
Email uro061@osaka-med.ac.jp

Sponsor
Institute Urology of Osaka Medical College
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020811

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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