UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002440 |
|---|---|
| Receipt number | R000002880 |
| Scientific Title | The effect of Ezetimibe in hypercholesterolemic patients with Nonaicoholic fatty liver disease(NAFLD) |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2009/09/03 14:04:03 |
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Basic information
Public title
The effect of Ezetimibe in hypercholesterolemic patients with Nonaicoholic fatty liver disease(NAFLD)
Acronym
The effect of Ezetimibe in patients with Nonaicoholic fatty liver disease(NAFLD)
Scientific Title
The effect of Ezetimibe in hypercholesterolemic patients with Nonaicoholic fatty liver disease(NAFLD)
Scientific Title:Acronym
The effect of Ezetimibe in patients with Nonaicoholic fatty liver disease(NAFLD)
Region
| Japan |
Condition
Condition
Nonaicoholic fatty liver disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate effect of ezetimibe in hypercholesterolemic patients with nonalcoholic fatty liver disesase(NAFLD)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Histological and immunohistochemical analysis of analysis of liver
2) L/S ratio by CT
3) Various biological markers of liver didease.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ezetimibe
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
hypercholesterolemic patients with NAFLD meeting following status:
1.diagnosed NAFLD by liver biopsy
2.continuing current treatment over
3months
3.over 20years old
Key exclusion criteria
1.patients being taken Ezetimibe
2.patients with serious liver disease
3.secondary hyperlipidemia or drug-induced hyperlipidemia
4.pregnant or lactating women
5.aicoholconsumption>21g/day
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Okanoue |
Organization
Saiseikai Suita Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
1-2 Kawazonocho, Suita, 564-0013, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Saiseikai Suita Hospital
Division name
Internal medicine
Zip code
Address
TEL
Homepage URL
parkh50@hotmail.com
Sponsor or person
Institute
Saiseikai Suita Hospital
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
| 2009 | Year | 10 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 03 | Day |
Last modified on
| 2009 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002880
| 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 |
