UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013611 |
|---|---|
| Receipt number | R000015897 |
| Scientific Title | The lowering effect of ezetimibe on serum lipids and serum lipoprotein in postprandial hyperlipidemi |
| Date of disclosure of the study information | 2014/04/02 |
| Last modified on | 2015/02/06 12:19:04 |
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Basic information
Public title
The lowering effect of ezetimibe on serum lipids and serum lipoprotein in postprandial hyperlipidemi
Acronym
The lowering effect of ezetimibe on serum lipids and serum lipoprotein in postprandial hyperlipidemi
Scientific Title
The lowering effect of ezetimibe on serum lipids and serum lipoprotein in postprandial hyperlipidemi
Scientific Title:Acronym
The lowering effect of ezetimibe on serum lipids and serum lipoprotein in postprandial hyperlipidemi
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus with hyperlipidemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the changes in serum remnant, lipid composition, fatty acid, cholesterol absorption marker during fat loading test and to compare the improvement of postprandial hyperlipidemia between pravastatin treated phase and ezetimibe treated phase.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The value of RLP-C 4 hour after fat loading test
Key secondary outcomes
Value of serum lipid and AUC after fat loading test
A value of blood glucose and AUC after fat loading test
Changes in serum lipid during study period
Changes in glycometabolism during study period
Side effect
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
Ezetimibe 10mg
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
Dyslipidemia patient with type 2 diabetes mellitus who fulfills enrollment criteria and who does not correspond to any of exclusion criteria below.
1)Age 20-
2)Postprandial TG 150mg/dL
3)LDL-C<120mg/dL with current therapy
4)Continues 3 months or longer lifestyle intervention and HbA1c<8%(NGSP) for 3 months
5)Understands the purpose, aim and method of this study, and with written consent.
Key exclusion criteria
1)Type 1 or secondary diabetes mellitus
2)With strong statin
3)With insulin
4)With Severe ketosis, diabetic coma or precoma
5)With any of myocardial infarction, angina pectoris, intracranial hemorrhage or cerebral infarction within 6 months
6)With moderate renal dysfunction(Serum CRE male:<1.4mg/dL, female:<1.2mg/dL)
7)With heart failure(HF) or history of HF
8)With severe hepatic dysfunction
9)With severe infection, perioperative period or severe injury
10)Patient who is pregnant, in lactation or suspected to be pregnant
11)Judged to be inadequate for including this study by PI or collaborators.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Osonoi |
Organization
Nakakinen clinic
Division name
Director
Zip code
Address
745-5, Nakadai, Naka, Ibaraki
TEL
029-353-2800
t-osonoi@kensei-kai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Ofuchi |
Organization
Nakakinen clinic
Division name
Clinical Laboratory
Zip code
Address
745-5, Nakadai, Naka, Ibaraki
TEL
029-353-2800
Homepage URL
k-ofuchi@kensei-kai.com
Sponsor or person
Institute
Nakakinen clinic
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
那珂記念クリニック
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 02 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 02 | Day |
Last modified on
| 2015 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015897
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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