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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005775
Receipt No. 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

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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
Email 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
Email miwa-t@tokyo-med.ac.jp

Sponsor
Institute The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006824

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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