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Value of oxidant lipid lowering effect by statin intervension in hypercholesterolemia.

Phase 4
Conditions
Hypercholesterolemia
Registration Number
JPRN-UMIN000001783
Lead Sponsor
Jikei University Kashiwa Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
(1)Change and percent change in oxidized Lp(a) lipoprotein. (2)Change and percent change in oxidized LDL.
Secondary Outcome Measures
NameTimeMethod
(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.
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