UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001073 |
|---|---|
| Receipt number | 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 17:36:41 |
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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
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
tommmish@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine Department of Cardiorenal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001305
