UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005775 |
|---|---|
| Receipt number | R000006824 |
| Scientific Title | Assessment of efficacy and safety of ezetimibe in patients with dyslipidemia complicated insulin resistance. |
| Date of disclosure of the study information | 2011/06/20 |
| Last modified on | 2019/12/25 12:42:49 |
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Basic information
Public title
Assessment of efficacy and safety of ezetimibe in patients with dyslipidemia complicated insulin resistance.
Acronym
Assessment of efficacy and safety of ezetimibe in patients with dyslipidemia complicated insulin resistance.
Scientific Title
Assessment of efficacy and safety of ezetimibe in patients with dyslipidemia complicated insulin resistance.
Scientific Title:Acronym
Assessment of efficacy and safety of ezetimibe in patients with dyslipidemia complicated insulin resistance.
Region
| Japan |
Condition
Condition
Dyslipidemia complicated insulin resistance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of the improvement on the insulin resistance and the internal organs obesity and the fatty liver of Ezetimib for the patients with dyslipidemia complicated insulin resistance is clarified.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Flow Mediated Dilation test
2)Volume of visceral fat and fatty liver)
3)Improvement ratio of Cholesterol Absorption and Synthesis Markers
4)Improvement ratio of Oxidized low density lipoprotein and Atherogenic lipoprotein level
3)
Key secondary outcomes
1)Improvement ratio of glucose metabolism makers
2)Improvement of inflammatory makers and Oxidation makers
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
Take Ezetimib:10mg/day for 12 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)LDL-C>=120mg/dL
2)Patients not change drug therapy for anti-dyslipidemic and/or anti-diabetic agent within 12weeks of the study entry.
3)HOMA-IR>=2.5 or BMI>=25
Key exclusion criteria
1)HbA1c>=8%
2)Patients with anamnesis for anaphylaxis of ezetimibe tablets
3)Complicated with Severe renal and/or hepatic disease
4)Having anamnesis of myocardial infarction, angina and/or stroke
5)Patients with secondary hyperlipidemia or drug-associated hyperlipidemia
6)Patients who are pregnant or lactating women and women suspected of being pregnant
7)Patients of Familial hyperlipidemia
8)Other patients deemed not appropriate for study entry by the investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Odawara |
| Middle name | |
| Last name | Masato |
Organization
Tokyo Medical University
Division name
The Department of Diabetes, Endocrinology and Metabolism
Zip code
1600023
Address
6-7-1 Nishi Shinjuku, Shinjuku-ku, Tokyo 160-0023
TEL
03-3342-6111
odawara@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Takashi |
Organization
Tokyo Medical University
Division name
The Department of Diabetes, Endocrinology and Metabolism
Zip code
1600023
Address
6-7-1 Nishi Shinjuku, Shinjuku-ku, Tokyo 160-0023
TEL
03-3342-6111
Homepage URL
miwa-t@tokyo-med.ac.jp
Sponsor or person
Institute
The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical University Hospital
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
Tokyo Medical University
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo
Tel
0333426111
kenkyu-s@tokyo-med.ac.jp
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
東京医科大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 20 | 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
47
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because paper is being submitted.
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 | 28 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 14 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006824
