UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004462 |
|---|---|
| Receipt number | 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 08:54:24 |
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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
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
sugimoto@geriat.med.osaka-u.ac.jp
Sponsor or person
Institute
Geriatric Medicine, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005340
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
