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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001783
Receipt No. 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

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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
Email 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
Email hyoshida@jikei.ac.jp

Sponsor
Institute Jikei University Kashiwa Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002128

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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