UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000717 |
|---|---|
| Receipt number | R000000853 |
| Scientific Title | Efficacy of rosuvastatin for the treatment of nonalcoholic steatohepatitis with hyperlipidemia |
| Date of disclosure of the study information | 2007/06/01 |
| Last modified on | 2012/11/14 09:59:49 |
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Basic information
Public title
Efficacy of rosuvastatin for the treatment of nonalcoholic steatohepatitis with hyperlipidemia
Acronym
Effect of rosuvastatin on NAFLD
Scientific Title
Efficacy of rosuvastatin for the treatment of nonalcoholic steatohepatitis with hyperlipidemia
Scientific Title:Acronym
Effect of rosuvastatin on NAFLD
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 investigate the efficacy of rosuvastatin for the treatment of nonalcoholic fatty liver disease with hyperlipidemia.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
liver transaminases
Key secondary outcomes
1.liver histology, 2.adipocytokines,3.liver fibrosis marker,4.glucose metabolism
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.NAFLD with hypercholesterolemia
Key exclusion criteria
1.patient with previous administration of rosuvastatin
2.patient with other origin of hepatitis than NASH
3.patient with allergy for rosuvastatin
4.patient with severe liver damage or obstructive biliary disease
5.patient recieving cyclosporin.
6. pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Chayama |
Organization
Graduate School of Biomedical Sciences, Hiroshima University.
Division name
Department of Medicine and Molecular Science
Zip code
Address
Kasumi1-2-3, Minamiku, Hiroshima city, Hiroshima,Japan. 734-8551
TEL
082-257-5190
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Hyogo |
Organization
Graduate School of Biomedical Sciences, Hiroshima University.
Division name
Department of Medicine and Molecular Science
Zip code
Address
TEL
082-257-5190
Homepage URL
hidehyogo@aol.com
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Molecular Science, Graduate School of Biomedical Sciences, Hiroshima University.
Organization
Division
Category of Funding Organization
Self funding
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
| 2007 | Year | 06 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 02 | Month | 15 | Day |
Other
Other related information
This study will be carried out from June 1st 2007.
Management information
Registered date
| 2007 | Year | 05 | Month | 14 | Day |
Last modified on
| 2012 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000853
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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