UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on efficacy of Ezetimibe in patients with Dyslipidemia associated with Digestive disease-Its effect on biliary bigly metabolism-
Title of the study (Brief title)	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	Tazuma Susumu
Organization	Hiroshima University hospital
Division name	Department of General Medicine
Address	1-2-3,Kasumi,Minami-Ku,Hiroshima
TEL	082-257-5461
Email

Public contact
Name of contact person	Tazuma Susumu
Organization	Hiroshima University hospital
Division name	Department of General Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000004912