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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001167
Receipt No. 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 2010/01/22

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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
Obsterics 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
Middle name
Last name Yukihito Higashi
Organization Hiroshima university graduate school of biomedical science
Division name Department of cardiovascular physiology and medicine
Zip code
Address 1-2-3kasumi, minamiku, hiroshima
TEL 082-257-5555
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yukihito Higashi
Organization Hiroshima university graduate school of biomedical science
Division name Department of cardiovascular physiology and medicine
Zip code
Address 1-2-3kasumi, minamiku, hiroshima
TEL 082-257-5555
Homepage URL
Email yhigashi@hiroshima-u.ac.jp

Sponsor
Institute Department of cardiovascular physiology and medicine, Hiroshima university graduate school of biomedical science
Institute
Department

Funding Source
Organization Ministry of Education, Science and Culture
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
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
Date of protocol fixation
2008 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2008 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
2010 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001429

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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