UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002954 |
|---|---|
| Receipt number | 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 15:34:10 |
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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
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
t086028f@yokohama-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Yokohama City University
Department of Endocrinology & Metabolism
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003592
