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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009328
Receipt No. R000010953
Scientific Title Surveillance study of the frequency of the primary aldosteronism included in the hypertensive patient for an untreated hypertensive patient at the time of the first medical examination: multi-center survey.
Date of disclosure of the study information 2012/11/13
Last modified on 2013/03/21

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Basic information
Public title Surveillance study of the frequency of the primary aldosteronism included in the hypertensive patient for an untreated hypertensive patient at the time of the first medical examination: multi-center survey.
Acronym The survey of primary aldosteronism.
Scientific Title Surveillance study of the frequency of the primary aldosteronism included in the hypertensive patient for an untreated hypertensive patient at the time of the first medical examination: multi-center survey.
Scientific Title:Acronym The survey of primary aldosteronism.
Region
Japan

Condition
Condition Primary aldosteronism
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarify the frequency of the primary aldosteronism in untreated hypertensive patients.
Basic objectives2 Others
Basic objectives -Others Contribute to a hypertensive patient's treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of primary aldosteronism
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 The hypertensive patient who is not treated at the time of the first medical examination.
The patient who has not taken the hypotensive drug one month or more.
Key exclusion criteria The patient who is taking a hypotensive drug.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Sugawara
Organization Japan Physicians Association
Division name Medical Committee
Zip code
Address 2-5 Kandasurugadai, Chiyoda-ku, Tokyo Pref. 101-0062, Japan
TEL 03-3259-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toru Setoyama
Organization Japan Physicians Association
Division name Secretariat
Zip code
Address 2-5 Kandasurugadai, Chiyoda-ku, Tokyo Pref. 101-0062, Japan
TEL 03-3259-6111
Homepage URL http://www.japha.jp
Email jpa@oregano.ocn.ne.jp

Sponsor
Institute Japan Physicians Association
Institute
Department

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
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
2012 Year 11 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information ARR>200,
PRA;below 1.0ng/ml/hr and PAC above 150pg/ml

Management information
Registered date
2012 Year 11 Month 13 Day
Last modified on
2013 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010953

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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