UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005540 |
|---|---|
| Receipt number | R000006436 |
| Scientific Title | Effect of Ezetimibe on visceral fat suppression in patients with chronic liver disease and hyperlipidemia ; a randomized, double blind, placebo-controlled, clinical trial |
| Date of disclosure of the study information | 2011/05/02 |
| Last modified on | 2013/04/02 15:37:24 |
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Basic information
Public title
Effect of Ezetimibe on visceral fat suppression in patients with chronic liver disease and hyperlipidemia ; a randomized, double blind, placebo-controlled, clinical trial
Acronym
Effect of Ezetibmibe on viceral fat suppression in patients with chronic liver disease and hyperlipidemia.
Scientific Title
Effect of Ezetimibe on visceral fat suppression in patients with chronic liver disease and hyperlipidemia ; a randomized, double blind, placebo-controlled, clinical trial
Scientific Title:Acronym
Effect of Ezetibmibe on viceral fat suppression in patients with chronic liver disease and hyperlipidemia.
Region
| Japan |
Condition
Condition
chronic liver disease with hyperlipidemia
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of ezetimibe on visceral fat suppression in patients with chronic liver disease and hyperlipidemia; a randomized, doubleblind, placebo-controlled, clinical trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The change in visceral fat
(measured by helical CT scan)
Key secondary outcomes
1)The change in serum viral genome every four weeks
2)The change in serum lipid or lipid marker levels
3)The change in serum ALT
4)The analysis of Liver tissue and lipid marker level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subjects will be assigned randomly to Ezetimibe treated group. Subjects will be received one capsule(Ezetimibe 10mg/day, and Lactose) once a day for 12weeks.
Interventions/Control_2
Subjects will be assinged randomly to placebo treated group. Subjects will be received one placebo capsule (Lactose) once a day for 12weeks.
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.Outpatients with chronic liver disease over the age of 20 in our hospital.
2.BMI 22.5kg/m2 or more.
3.Patients We obtained written informed consent for participation in the study.
Key exclusion criteria
1.Subjects during pregnancy, feeding, intimation of pregnancy or intended pregnancy
2.Subjects who have already treated with interferon and ribavirin
3.Subjects who have already treated with steroids, immunosuppressive agent, and antitumor agent.
4.Other,Subjects deemed unsuitable for the doctor
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Morimoto |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akito Nozaki |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
Sponsor or person
Institute
Yokohama City University Medical Center Gastroenterological Center
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 02 | 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
| 2011 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | 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
| 2011 | Year | 05 | Month | 02 | Day |
Last modified on
| 2013 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006436
