UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003932 |
|---|---|
| Receipt number | R000004726 |
| Scientific Title | Effectiveness of Ezetimibe in NAFLD patients with hyperlipidemia |
| Date of disclosure of the study information | 2010/07/26 |
| Last modified on | 2014/06/02 15:06:06 |
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Basic information
Public title
Effectiveness of Ezetimibe in NAFLD patients with hyperlipidemia
Acronym
Effectiveness of Ezetimibe in NAFLD patients with hyperlipidemia
Scientific Title
Effectiveness of Ezetimibe in NAFLD patients with hyperlipidemia
Scientific Title:Acronym
Effectiveness of Ezetimibe in NAFLD patients with hyperlipidemia
Region
| Japan |
Condition
Condition
Non-alcholic fatty liver disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of Ezetimibe in NAFLD patients with hyperlipidemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before and after 6 months of Ezetimibe (10mg/day) to NAFLD patients. We assessed Liver tranceminases and lipid levels.
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
Ezetimibe 10mg/day
Interventions/Control_2
diet and exercise
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 Non-drinking patient
2 Patients with other origin of hepatitis than NAFLD
3 Patients with NAFLD
4 Patients with hyperlipdemia
Key exclusion criteria
1 Patient with allergy for ezetimibe
2 The following patients with grave hepatic dysfunction when use ezetimibe together with statin a)acute exacerbation of acute hepatitis , chronic hepatitis
b)cirrhosis , hepatoma , choloplania(child B or more)
3 Pregnancy , women who may possibly be of pregnant
4 Patients with a history of arteriosclerotic disease
5 Patients with secondary hyperlipidemia, drug-induced dyslipidemia
6 Patients who judged that examination doctor in charge is improper
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Fujii |
Organization
Osaka City University Medical School
Division name
Department of Hepatology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
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 Medical School
Division name
Department of Hepatology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3811
Homepage URL
rolahideki@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Hepatology, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Osaka City 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
| 2010 | Year | 07 | Month | 26 | 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 | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 20 | 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=R000004726
