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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002954
Receipt No. R000003592
Scientific Title Effects of ezetimibe on postprandial hyperlipidaemia and hyperglycemia in Japanese hyperlipidemic patients; Double-blinded crossover randomized clinical trial
Date of disclosure of the study information 2010/01/05
Last modified on 2011/12/28

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Basic information
Public title Effects of ezetimibe on postprandial hyperlipidaemia and hyperglycemia in Japanese hyperlipidemic patients; Double-blinded crossover randomized clinical trial
Acronym Effects of ezetimibe on postprandial hyperlipidaemia and hyperglycemia
Scientific Title Effects of ezetimibe on postprandial hyperlipidaemia and hyperglycemia in Japanese hyperlipidemic patients; Double-blinded crossover randomized clinical trial
Scientific Title:Acronym Effects of ezetimibe on postprandial hyperlipidaemia and hyperglycemia
Region
Japan

Condition
Condition hyperlipidemic subjects
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effects of ezetimibe on postprandial hyperglycemia and hyperlipidemia in obese subjects with dyslipidemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.The change in serum lipid levels(TG,Apo48,RLP-C, oxidized cholesterol)
Key secondary outcomes 1.The alteration in glucose metabolism
2.The change in serum hs-CRP, TNF-
3.The change in serum total adiponectin concentration

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Subjects will be assigned randomly to ezetimibe precedence treated group and placebo precedence treated group.Subjects in ezetimibe precedence treated group will be received ezetimibe 10 mg/day for the first month and placebo for another one month after one month interval.
Interventions/Control_2 Subjects will be assigned randomly to ezetimibe precedence treated group and placebo precedence treated group.Subjects in placebo precedence treated group will be received placebo for the first month and ezetimibe 10 mg/day for another one month after one month interval
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
65 years-old >=
Gender Male
Key inclusion criteria 1.waist 85cm or more, BMI 25kg/m2 or more
2.TG:150~400 mg/dL
Key exclusion criteria 1.Subjects who are hypersensitive to this medicine and/or contaminants of this medicine.
2.Subjects who have a severe hepatic or renal dysfunction.
3.Subjects who have already been treated with anti-dyslipidemic and/or anti-diabetic agent within 3 months of the study entry
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Terauchi
Organization Graduate School of Medicine, Yokohama City University
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL +45-787-2639
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kaori Kikuchi
Organization Graduate School of Medicine, Yokohama City University
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL +45-787-2639
Homepage URL
Email t086028f@yokohama-cu.ac.jp

Sponsor
Institute Graduate School of Medicine, Yokohama City University
Department of Endocrinology & Metabolism
Institute
Department

Funding Source
Organization Graduate School of Medicine, Yokohama City University
Department of Endocrinology & Metabolism
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 横浜市立大学大学院医学研究科
Yokohama City University Graduate School of Medicine

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 05 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 No longer recruiting
Date of protocol fixation
2009 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 28 Day
Last modified on
2011 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003592

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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