UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001167 |
|---|---|
| Receipt number | R000001429 |
| Scientific Title | Analysis of Rho kinase (ROCK) activity in subjects with cerebrocardiovascular risk factor |
| Date of disclosure of the study information | 2008/06/01 |
| Last modified on | 2023/06/12 08:40:38 |
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Basic information
Public title
Analysis of Rho kinase (ROCK) activity in subjects with cerebrocardiovascular risk factor
Acronym
ROCK study
Scientific Title
Analysis of Rho kinase (ROCK) activity in subjects with cerebrocardiovascular risk factor
Scientific Title:Acronym
ROCK study
Region
| Japan |
Condition
Condition
Hypertension, Diabetes mellitus, Hyperlipidemia, Cigarette smoking, Coronary heart disease, Cerebrovascular disease, Peripheral artery disease, Arteriosclerosis
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Nephrology | Neurology | Vascular surgery |
| Obstetrics and Gynecology | Neurosurgery | Cardiovascular surgery |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the implication of ROCK activity in peripheral leukocytes in the progression of atherosclerotic disease burden.
Basic objectives2
Others
Basic objectives -Others
To analyze the relation between ROCK activity in peripheral leukocytes and inflammation or endothelial function.
To evaluate leukocyte ROCK activity in patients with hypertension treated with antihypertensive drugs.
To evaluate the effect of the calcium channel blocker amlodipine on leukocyte ROCK activity before and after 4 and 12 weeks of treatment in patients with essential hypertension.
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
ROCK activity, number of coronary risk factor and morbidity of atherosclerotic disease burden, Endothelial function, number of endothelial progenitor cell,CRP, LV hypertrophy and LV diastolic function.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antihypertensive agent (amlodipine)
Interventions/Control_2
Antihypertensive agent (losartan)
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects with cerebrocardiovascular disease or their risk factors.
Key exclusion criteria
Subjects without informed consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yukihito |
| Middle name | |
| Last name | Higashi |
Organization
Hiroshima university graduate school of biomedical science
Division name
Department of cardiovascular physiology and medicine
Zip code
731-3167
Address
1-2-3kasumi, minamiku, hiroshima
TEL
082-257-5555
yhigashi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihito |
| Middle name | |
| Last name | Higashi |
Organization
Hiroshima university graduate school of biomedical science
Division name
Department of cardiovascular physiology and medicine
Zip code
731-3167
Address
1-2-3kasumi, minamiku, hiroshima
TEL
082-257-5555
Homepage URL
yhigashi@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of cardiovascular physiology and medicine, Hiroshima university graduate school of biomedical science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Science and Culture
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Hiroshima University
Address
minami-ku, Kasumi
Tel
0822575555
yhigashi@hiroshima-u.ac.jp
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
| 2008 | Year | 06 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2008 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Currently, registered in the population.
Management information
Registered date
| 2008 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001429
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
