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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001073
Receipt No. R000001305
Scientific Title Examinations for the usefullness of new home blood pressure monitoring devices compared with ambulatory blood pressure monitoring devices.
Date of disclosure of the study information 2020/04/01
Last modified on 2009/11/11

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Basic information
Public title Examinations for the usefullness of new home blood pressure monitoring devices compared with ambulatory blood pressure monitoring devices.
Acronym Comarison between new HBP monitoring and ABPM
Scientific Title Examinations for the usefullness of new home blood pressure monitoring devices compared with ambulatory blood pressure monitoring devices.
Scientific Title:Acronym Comarison between new HBP monitoring and ABPM
Region
Japan

Condition
Condition healthy volunteers and subjects with essential hypertension
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefullness of new HBP monitoring devices compared with ABPM.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes home BP, night BP, heart rate variability
results of questionnaire
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 Subjects agree with informed consents.
Key exclusion criteria none
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoaki Ishigami
Organization Yokohama City University Graduate School of Medicine
Division name Department of Medicine and Cardio-renal Medicine
Zip code
Address Fukuura, Kanazawa-ku, Yokohama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuaki Uchino
Organization Yokohama City University
Division name Department of Medicine and Cardio-renal Medicin
Zip code
Address Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2635
Homepage URL
Email tommmish@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine Department of Cardiorenal Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine Department of Cardiorenal Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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
2020 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results 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
2007 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Home BP, Night BP, Casual BP, Daytime Variation

Management information
Registered date
2008 Year 03 Month 11 Day
Last modified on
2009 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001305

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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