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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004183
Receipt No. R000004912
Scientific Title A study on efficacy of Ezetimibe in patients with Dyslipidemia associated with Digestive disease-Its effect on biliary bigly metabolism-
Date of disclosure of the study information 2010/09/10
Last modified on 2017/09/25

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Basic information
Public title A study on efficacy of Ezetimibe in patients with Dyslipidemia associated with Digestive disease-Its effect on biliary bigly metabolism-
Acronym A study on efficacy of Ezetimibe in patients with Dyslipidemia associated with Digestive disease
Scientific Title A study on efficacy of Ezetimibe in patients with Dyslipidemia associated with Digestive disease-Its effect on biliary bigly metabolism-
Scientific Title:Acronym A study on efficacy of Ezetimibe in patients with Dyslipidemia associated with Digestive disease
Region
Japan

Condition
Condition hypercholesterolemia
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of ezetimibe in patients with Dyslipidemia associated with Digestive disease for the comparison of improvement of the clinical parameters and bile composition
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Before and after 6 months of Ezetimibe to clinical effectiveness and bile composition
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients with hypercholesterolemia(LDL-C of 14mg/dL or more)
Key exclusion criteria 1)Patients who are treated with insulin
2)HbA1>=8%
3)History ofhypersensitivity to Ezetimibe
4)Serious hepatic disfunctions
5)Patient whom biliary tract comletely blockaded
6)Serious kidney disfunctions
7)AMI,angina and stroke within 3 months before intervention
8)Secondary hypercholesterolemia or medical hypercholesterolemia
9)Pregnant or lactating women and women who may be pregnant
10)Familial hypercholesterolemia
11)Bronchial Asthma or an allergic disease
12)Judged by investigator not to be appropriate for inclusion in this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tazuma Susumu
Organization Hiroshima University hospital
Division name Department of General Medicine
Zip code
Address 1-2-3,Kasumi,Minami-Ku,Hiroshima
TEL 082-257-5461
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tazuma Susumu
Organization Hiroshima University hospital
Division name Department of General Medicine
Zip code
Address 1-2-3,Kasumi,Minami-Ku,Hiroshima
TEL 082-257-5461
Homepage URL
Email stazuma@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University hospital
Department of General Medicine
Institute
Department

Funding Source
Organization Hiroshima University hospital
Department of General Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 広島大学病院(広島県)
東京医科大学茨城医療センター(茨城県)
東邦大学医療センター大森病院(東京都)
藤田保健衛生大学 坂文種報徳会病院(愛知県)
産業医科大学病院(北九州市)
島根大学医学部附属病院(島根県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2012 Year 11 Month 01 Day
Date of closure to data entry
2012 Year 11 Month 01 Day
Date trial data considered complete
2012 Year 11 Month 01 Day
Date analysis concluded
2012 Year 11 Month 01 Day

Other
Other related information Objectives:To investigate the efficacy of ezetimibe in patients with Dyslipidemia associated with Digestive disease for the comparison of improvement of the clinical parameters and bile composition

Primary outcomes:Before and after 6 months of Ezetimibe to clinical effectiveness and bile composition

Management information
Registered date
2010 Year 09 Month 10 Day
Last modified on
2017 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004912

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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