UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001718 |
|---|---|
| Receipt number | R000002056 |
| Scientific Title | Clinical study of the correlation between cholesterol absorption and coronary risk factors or arteriosclerotic diseases, and of the clinical significance of the controlling cholesterol absorption. |
| Date of disclosure of the study information | 2009/02/23 |
| Last modified on | 2011/08/16 17:20:56 |
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Basic information
Public title
Clinical study of the correlation between cholesterol absorption and coronary risk factors or arteriosclerotic diseases, and of the clinical significance of the controlling cholesterol absorption.
Acronym
Clinical study of the inhibition of cholesterol absorption.
Scientific Title
Clinical study of the correlation between cholesterol absorption and coronary risk factors or arteriosclerotic diseases, and of the clinical significance of the controlling cholesterol absorption.
Scientific Title:Acronym
Clinical study of the inhibition of cholesterol absorption.
Region
| Japan |
Condition
Condition
Hypercholesterolemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the association between the balance of cholesterol synthesis/absorption and coronary risk factors or arteriosclerotic diseases. We also assess clinical usefulness of Ezetimibe, a small intestine cholesterol transporter inhibitor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Association between the cholesterol asynthesis/absorption markers before Ezetimibe administration and coronary risk factors or arteriosclerotic diseases.
2. Amount or rate of changes in LDL-C after Ezetimibe administration.
3. Correlation between the amount or rate of changes in LDL-C after Ezetimibe administration and the cholesterol synthesis/absorption markers.
Key secondary outcomes
Changes of RLP-cholesterol, HDL-C, triglyceride, insulin, plasma glucose, HbA1c, and hs-CRP.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Twelve weeks Ezetimibe administration to the patients with hypercholesterolemia without statins.
Interventions/Control_2
Twelve weeks Ezetimibe administration to the patients with hypercholesterolemia taking statins.
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
Serum LDL-C level is higher than the management targeted value in Japan atherosclerosis society guidelines for prevention of atherosclerotic cardiovascular diseases 2007.
Key exclusion criteria
Severe liver or renal dysfunction.
The patient using fibrate or insulin.
Secondary hypercholesterolemia.
Pregnant women.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamitsu Nakazato |
Organization
Miyazaki Medical College, University of Miyazaki
Division name
Neurology, Respirology, Endocrinology and Metabolism
Zip code
Address
5200, kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-2965
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ueno |
Organization
Miyazaki Medical College, University of Miyazaki
Division name
Neurology, Respirology, Endocrinology and Metabolism
Zip code
Address
5200, kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-2965
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Neurology, Respirology, Endocrinology and Metabolism,
Miyazaki Medical College, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science & technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 02 | Month | 23 | 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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 19 | Day |
Last modified on
| 2011 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002056
