UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009614 |
|---|---|
| Receipt number | R000011278 |
| Scientific Title | Analysis of nonalcoholic steatohepatitis and the risk of cardiovascular event in terms of lipid metabolism abnormality |
| Date of disclosure of the study information | 2012/12/25 |
| Last modified on | 2013/12/27 17:09:20 |
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Basic information
Public title
Analysis of nonalcoholic steatohepatitis and the risk of cardiovascular event in terms of lipid metabolism abnormality
Acronym
Analysis of nonalcoholic steatohepatitis and the risk of cardiovascular event
Scientific Title
Analysis of nonalcoholic steatohepatitis and the risk of cardiovascular event in terms of lipid metabolism abnormality
Scientific Title:Acronym
Analysis of nonalcoholic steatohepatitis and the risk of cardiovascular event
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the risk of cardiovascular event in nonalcoholic fatty liver disease in terms of lipid metabolism abnormality and whether the lipid-lowering drug reduces the risk of cardiovascular event in nonalcoholic fatty liver disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Small dense LDL cholesterol and non-HDL cholesterol
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
control
Interventions/Control_2
lipid-lowering drug
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with NAFLD diagnosed by liver biopsy
Key exclusion criteria
Subjects with a history of excessive alcohol consumption (>140 g/week for men, >70 g/week for women), other liver diseases, drug use associated with fatty liver, or weight reduction were excluded
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2640
kento318@yohokama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kento Imajo |
Organization
Yokohama City University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
Address
3-9, Fuku-ura, Kanazawaku, Yokohama city
TEL
045-787-2640
Homepage URL
kento318@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 25 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 12 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 22 | Day |
Last modified on
| 2013 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011278
