UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004183
Receipt number 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 21:31:27

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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 or person

Institute

Hiroshima University hospital
Department of General Medicine

Institute

Department

Personal name



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

Value
https://center6.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