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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004462
Receipt No. R000005340
Scientific Title The study for beneficial efficacy and safety of ezetimibe in patients with hyper LDL-cholesterolemia associated with diabetes mellitus (DM) including glucose intolerance and non-alcoholic fatty liver disease (NAFLD)
Date of disclosure of the study information 2010/11/01
Last modified on 2014/04/28

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Basic information
Public title The study for beneficial efficacy and safety of ezetimibe in patients with hyper LDL-cholesterolemia associated with diabetes mellitus (DM) including glucose intolerance and non-alcoholic fatty liver disease (NAFLD)
Acronym The study for beneficial efficacy of ezetimibe in patients with hyper LDL-cholesterolemia with diabetes and NAFLD
Scientific Title The study for beneficial efficacy and safety of ezetimibe in patients with hyper LDL-cholesterolemia associated with diabetes mellitus (DM) including glucose intolerance and non-alcoholic fatty liver disease (NAFLD)
Scientific Title:Acronym The study for beneficial efficacy of ezetimibe in patients with hyper LDL-cholesterolemia with diabetes and NAFLD
Region
Japan

Condition
Condition non-alcoholic fatty liver disease, diabetes mellitus, hyper LDL-cholesterolemia
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate LDL-cholesterol lowering effect of ezetimibe and the inhibitory effect of ezetimibe on hepatic steatosis in human
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The rate of change in LDL-cholesterol level after 24 weeks from entry
Key secondary outcomes 1) the rate of change of fat accumulation in liver by abdominal ultrasound
2) the rate of change of hepatic function test
3) the rate of change of glucose tolerance
4) the rate of change of serum lipid level other than LDL-cholesterol
5) the rate of change of inflammatory markers
6) the rate of change of oxidative stress markers
7) safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 the administration of ezetimibe, 10mg per day
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The outpatients with less than 180mg/dl of LDL-cholestrol level and without achieving the management target set in Guidelines for Cardiovascular Disease Prevention 2007
Key exclusion criteria 1) the subjects currently receiving ezetimibe
2) the subjects infected with hepatitis B or C virus
3) the subjects with more than 500mg/dl of triglyceride
4) the subjects with familial hyperlipidemia, secondary hyperlipidemia and drug induced-hyperlipidemia
5) the subjects drinking alcohol more than 21g per day frequently
6) the subjects receiving pioglitazone
7) the subjects recommended the other medication
8) the subjects with hyperlipidemia induced by: hypothyroidism, obstructive biliary tract disease, pancreatitis, cushing syndrome, lupus erythematosus, malignant lymphoma, myeloma.
9) the subjects with poor controlled diabetes (HbA1c > 9.0%)
10) the subjects having a history of a previous drug allergy
11) the subjects during pregnancy or lactation
12) the subjects found offensive by attending physicians for this research
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromi Rakugi
Organization Osaka University Graduate School of Medicine
Division name Geriatric Medicine
Zip code
Address 2-2, #B6, Yamada-oka, Suita, Osaka, Japan
TEL 06-6879-3852
Email sugimoto@geriat.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Sugimoto
Organization Osaka University Graduate School of Medicine
Division name Geriatric Medicine
Zip code
Address 2-2, #B6, Yamada-oka, Suita, Osaka, Japan
TEL 06-6879-3852
Homepage URL
Email sugimoto@geriat.med.osaka-u.ac.jp

Sponsor
Institute Geriatric Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Geriatric Medicine, Osaka University Graduate School of Medicine
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 大阪大学医学部附属病院 老年・高血圧内科

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 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 Completed
Date of protocol fixation
2009 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 27 Day
Last modified on
2014 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005340

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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