UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005250 |
|---|---|
| Receipt number | R000006242 |
| Scientific Title | Efficacy of ezetimibe for the treatment of non-alcoholic fatty liver disease: A randomized, controlled trial |
| Date of disclosure of the study information | 2011/03/14 |
| Last modified on | 2011/03/14 23:16:32 |
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Basic information
Public title
Efficacy of ezetimibe for the treatment of non-alcoholic fatty liver disease: A randomized, controlled trial
Acronym
Efficacy of ezetimibe for the treatment of non-alcoholic fatty liver disease: A randomized, controlled trial
Scientific Title
Efficacy of ezetimibe for the treatment of non-alcoholic fatty liver disease: A randomized, controlled trial
Scientific Title:Acronym
Efficacy of ezetimibe for the treatment of non-alcoholic fatty liver disease: A randomized, controlled trial
Region
| Japan |
Condition
Condition
non-alcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We therefore investigated the efficacy of Ezetimibe treatment for NAFLD patients by an open-label randomized, controlled trial. In this study, we compared the alterations of not only clinical parameters but also histological findings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical parameters and liver histologyin NAFLD were evaluated before and after the treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ezetimibe
Interventions/Control_2
control
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
1) NAFLD in histology
2) dyslipidemia TC 220mg/dl or higher
or treatment to dyslipidemia has already been done.
3) Case it is possible to take ezetimibe about six months
4) Child-Pugh A
5) 20-80 years old age when registering
6) Performance status(ECOG scale) is 0 or 1
7) Key organ function is maintained by clinical examination within 14 days before it registers.
Key exclusion criteria
Patients will be excluded from the study if they meet any of the following criteria:
1)hepatic virus infections (hepatitis B and C)
2)the current or past consumption of more than 20 g of alcohol daily
3)concurrent hepatocellular carcinoma, as determined by diagnostic imaging results
4) hepatic encephalopathy
5) active infections
6) severe complication
7) Woman who has possibility of pregnancy or pregnancy or while suckling.
8)Case to whom medicine in which it is using together taboo of ezetimibe and describes attention of using together is administered
9) those who are inadequate for this study as assessed by the investigators
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eishiro Mizukoshi |
Organization
Kananzawa University Graduate School of Medical Science
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2233
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eishiro Mizukoshi |
Organization
Kananzawa University Graduate School of Medical Science
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
Homepage URL
Sponsor or person
Institute
Eishiro Mizukoshi
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Graduate School of Medical Science
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
金沢大学医学部附属病院 （石川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 14 | 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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 14 | Day |
Last modified on
| 2011 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006242
| 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 |
