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
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
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
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 | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
