UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009187 |
|---|---|
| Receipt number | R000010699 |
| Scientific Title | Usefulness of a new method for evaluating autonomic nervous system function |
| Date of disclosure of the study information | 2012/10/29 |
| Last modified on | 2013/05/30 10:16:49 |
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Basic information
Public title
Usefulness of a new method for evaluating autonomic nervous system function
Acronym
Usefulness of a new method for evaluating autonomic nervous system function
Scientific Title
Usefulness of a new method for evaluating autonomic nervous system function
Scientific Title:Acronym
Usefulness of a new method for evaluating autonomic nervous system function
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulnes of a new method for evaluating autonomic nervous system function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CVRR L/H
ABPM
CAVI
Carotid Ultrasound Examination
ABI/PWV
blood chemical values
complete blood cell counts
urine test
apelin
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
Patients with atherosclerosis
Key exclusion criteria
Patients diagnosed with inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatshuo Hashimoto |
Organization
Yokohama City University
Division name
Nephology/Hypertension
Zip code
Address
9-3 fukuura kanazawaku yokohamasi
TEL
0457872635
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatshuo Hashimoto |
Organization
Yokohama City University
Division name
Nephology/Hypertension
Zip code
Address
9-3 fukuura kanazawaku yokohamasi
TEL
0457872635
Homepage URL
Sponsor or person
Institute
Nephology/Hypertension
Institute
Department
Personal name
Funding Source
Organization
Nephology/Hypertension
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
saiseikai yokohamasinannbu hospital
Kobayasi Clinic
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
横浜市立大学附属病院（神奈川県）、小林内科クリニック（神奈川県）
恩賜財団済生会横浜市南部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analyze the relationship between the test item and autonomic function in patients with arteriosclerosis
Management information
Registered date
| 2012 | Year | 10 | Month | 25 | Day |
Last modified on
| 2013 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010699
