UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003392 |
|---|---|
| Receipt number | R000004117 |
| Scientific Title | Effects of ezetimibe on postprandial hyperlipidemia. |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2012/09/28 21:03:17 |
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Basic information
Public title
Effects of ezetimibe on postprandial hyperlipidemia.
Acronym
Effects of ezetimibe on postprandial hyperlipidemia.
Scientific Title
Effects of ezetimibe on postprandial hyperlipidemia.
Scientific Title:Acronym
Effects of ezetimibe on postprandial hyperlipidemia.
Region
| Japan |
Condition
Condition
dyslipidemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of ezetimibe on postprandial hyperlipidemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of postprandial liipd levels (TG, apoB48, RLP-C)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ezetimibe monotherapy
Interventions/Control_2
TLC(diet & exercise)
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
The levels of TC are 220mg/dL and more or TG are150mg/dL and more.
Key exclusion criteria
1)TG > 400mg/dL
2)ATL levels > 2 times the upper limit of normal
3)Serum Cr levels > 3.0mg/dL
4) Patients with secondary hyperlipidemia or drug-associated hyperlipidemia
5)Homozygous familial hypercholesterolemia
6)Patients with a history of unstable angina, MI, CABG or stroke within 3 months of study entry
7) Patients who are pregnant or nursing mothers, patients who may be pregnant, or patients who want to become pregnant during participation in the study.
8) Patients with a history of hypersensitivity to any ingredient of ezetimibe tablets
9) Other patients deemed not appropriate for study entry by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Ohmura |
Organization
Juntendo University, School of Medicine
Division name
Cardiology
Zip code
Address
2-1-1 Bunkyo-ku Hongo Tokyo Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Ohmura |
Organization
Juntendo University, School of Medicine
Division name
Cardiology
Zip code
Address
TEL
Homepage URL
hohmura@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine, Cardiology
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine, Cardiology
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
順天堂大学医学部付属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 28 | Day |
Last modified on
| 2012 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004117
