UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005540
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Yokohama City University Medical Center Gastroenterological Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006436

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.