UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001783 |
|---|---|
| Receipt number | R000002128 |
| Scientific Title | Value of oxidant lipid lowering effect by statin intervension in hypercholesterolemia. |
| Date of disclosure of the study information | 2009/03/25 |
| Last modified on | 2014/03/18 14:23:46 |
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Basic information
Public title
Value of oxidant lipid lowering effect by statin intervension in hypercholesterolemia.
Acronym
Value of oxidant lipid lowering effect by statin intervention in hypercholesterolemia (VISION Study)
Scientific Title
Value of oxidant lipid lowering effect by statin intervension in hypercholesterolemia.
Scientific Title:Acronym
Value of oxidant lipid lowering effect by statin intervention in hypercholesterolemia (VISION Study)
Region
| Japan |
Condition
Condition
Hypercholesterolemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate effects of statins (pitavastatin and atorvastatin) for oxidized LDL/oxidized Lp(a) protein levels, serum lipid profile, and adverse events.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
(1)Change and percent change in oxidized Lp(a) lipoprotein.
(2)Change and percent change in oxidized LDL.
Key secondary outcomes
(1)Change and percent change in TC, LDL-C, TG and HDL-C.
(2)Change and percent change in apo A-1 and apo B.
(3)Change and percent change in Lp(a) protein and RLP-C.
(4)Change and percent change in Mg.
(5)Change of various serum lipoprotein cholesterol by HPLC.
(6)Change and percent change in vitamin E.
(7)Change and percent change in MDA-LDL.
(8)Change and percent change in adiponectin.
(9)Change and percent change in small dense LDL.
(10)Change and percent change in oxidized HDL.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pitavastatin group: administration of 2mg pitavastatin once a day for 12 weeks.
Interventions/Control_2
Atorvastatin group: administration of 10mg atorvastatin once a day for 12 weeks.
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
(1)Hypercholesterolemia or familial hypercholesterolemia.
(2)Inpatients or outpatients.
(3)Men aged 20 or older, or postmenopausal women.
(4)All patients were fully informed and gave written informed consent.
Key exclusion criteria
(1)Hypersensitivity for statin treatment.
(2)Hepatic disorder (AST or ALT >=100 IU/L), biliary atresia, or suspected hepatic metabolism disorders (acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer, and jaundice).
(3)Renal disorder (serum creatinine >= 1.5mg/dL).
(4)Receiving cyclosporine.
(5)Receiving probucol.
(6)Receiving tocopherol.
(7)Receiving hormone replacement therapy.
(8)Uncontrolled hypothyroidism.
(9)Pregnant women, women who may be pregnant, and breast-feeding women.
(10)Patients who were judged unsuitable by their doctor.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yoshida |
Organization
Jikei University Kashiwa Hospital
Division name
Department of Laboratory Medicine
Zip code
Address
163-1 Kashiwashita, Kashiwa, Chiba
TEL
04-7164-1111
hyoshida@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yoshida |
Organization
Jikei University Kashiwa Hospital
Division name
Department of Laboratory Medicine
Zip code
Address
163-1 Kashiwashita, Kashiwa, Chiba
TEL
04-7164-1111
Homepage URL
hyoshida@jikei.ac.jp
Sponsor or person
Institute
Jikei University Kashiwa Hospital
Institute
Department
Personal name
Funding Source
Organization
VISION Study group of Jikei University Kashiwa Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jikei University School Aoto Hospital
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
東京慈恵会医科大学附属柏病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The VISION study describes the first comparison on lipoprotein oxidation biomarkers between pitavastatin and atorvastatin and suggests diverse effects on lipoprotein oxidation markers in patients with hypercholesterolemia.
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
| 2005 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 01 | Day |
Other
Other related information
Principal results of this study was published in Atherosclerosis. 2013 Jan;226(1):161-4.
Management information
Registered date
| 2009 | Year | 03 | Month | 18 | Day |
Last modified on
| 2014 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002128
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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