UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001071 |
|---|---|
| Receipt number | R000001300 |
| Scientific Title | Efficacy of Ezetimibe for the patients with Non-alcoholic fatty liver disease (NAFLD) |
| Date of disclosure of the study information | 2011/06/30 |
| Last modified on | 2014/06/02 17:53:02 |
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Basic information
Public title
Efficacy of Ezetimibe for the patients with Non-alcoholic fatty liver disease (NAFLD)
Acronym
Ezetimibe therapy for Non-alcoholic fatty liver disease (NAFLD)
Scientific Title
Efficacy of Ezetimibe for the patients with Non-alcoholic fatty liver disease (NAFLD)
Scientific Title:Acronym
Ezetimibe therapy for Non-alcoholic fatty liver disease (NAFLD)
Region
| Japan |
Condition
Condition
Non-alcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of Ezetimibe for the patients with Non-alcoholic fatty liver disease (NAFLD)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes of AST, ALT, Total cholesterol, and LDL-cholesterol at month 6 after the start of therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The research dietitian instructed all subjects to reduce their caloric intake by 300 kcal per day. The subjects were randomly assigned to receive one of the regimens; in Group A, the patients will receive Ezetimibe at a dose of 10mg per day for 6 months.
Interventions/Control_2
The research dietitian instructed all subjects to reduce their caloric intake by 300 kcal per day. The subjects were randomly assigned to receive one of the regimens; in Group B, the patients will receive no drug for 6 months.
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. absence of clinically significant alcohol consumption (20g/day)
2. no other identifiable causes of liver diseases (infection with hepatitis B virus, hepatitis C virus, autoimmune liver diseases, and so on)
3. diagnosed as fatty liver by abdominal ultrasonography or CT
4. 180>LDL-C>140mg/dL
Key exclusion criteria
1. past history of hypersensitivity to Ezetimibe
2. clinical sighs of severe liver injury such as acute hepatitis, acute exacerbation of chronic hepatitis, cirrhosis in Child B or C, hepatocellular carcinoma, and jaundice in combination with Statin.
3. women who are or possibly pregnant
4. past history of atherosclerotic disease(myocardial infarction , angina pectoris, cerebral stroke, and so on).
5. secondry hyperlipidemia or drug induced hyperlipidemia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norifumi Kawada |
Organization
Osaka City University Graduate School of
Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3811
rolahideki@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Fujii |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3811
Homepage URL
rolahideki@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2011 | Year | 06 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 06 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 03 | Month | 09 | Day |
Last modified on
| 2014 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001300
| 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 |
