UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006866 |
|---|---|
| Receipt number | R000008117 |
| Scientific Title | Natriuretic effect On Blood pressure Under Natrium intake Assessment in Gifu Area |
| Date of disclosure of the study information | 2011/12/10 |
| Last modified on | 2018/10/31 18:29:21 |
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Basic information
Public title
Natriuretic effect On Blood pressure Under Natrium intake Assessment in Gifu Area
Acronym
NOBUNAGA study
Scientific Title
Natriuretic effect On Blood pressure Under Natrium intake Assessment in Gifu Area
Scientific Title:Acronym
NOBUNAGA study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship among salt-intake, Karium-intake, anti- hypertensive drugs, blood pressure and brain, kidney and cardiovascular events
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain event
Kidney event
Cardiovascular event
Key secondary outcomes
NaCl intake
K intake
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
Hypertensive patients who is or will be receiving anti-hypertensive drugs
Key exclusion criteria
Patients with dialysis,
Patients with pregnancy,
Patients whom a doctor judged as inappropriate to enroll
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Minatoguchi |
Organization
Gifu university graduate school of medicine
Division name
Cardiology
Zip code
Address
Yanagido 1-1, Gifu city, Gifu prefecture
TEL
058-230-6520
minatos@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Minatoguchi |
Organization
Gifu university graduate school of medicine
Division name
Cardiology
Zip code
Address
Yanagido 1-1, Gifu city, Gifu prefecture
TEL
058-230-6520
Homepage URL
minatos@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
岐阜大学病院（Gifu university hospital)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | 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
| 2011 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 01 | Day |
Other
Other related information
none
Management information
Registered date
| 2011 | Year | 12 | Month | 09 | Day |
Last modified on
| 2018 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008117
