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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005250
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Eishiro Mizukoshi
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006242

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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