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

UMIN ID: UMIN000001783

Registered date:25/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypercholesterolemia
• Date of first enrollment: 2006/04/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Pitavastatin group: administration of 2mg pitavastatin once a day for 12 weeks.
Atorvastatin group: administration of 10mg atorvastatin once a day for 12 weeks.

Outcome(s)

• Primary Outcome: (1)Change and percent change in oxidized Lp(a) lipoprotein. (2)Change and percent change in oxidized LDL.
• Secondary Outcome: (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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Jikei University Kashiwa Hospital
• Secondary Sponsor: Jikei University School Aoto Hospital
• Source(s) of Monetary Support: VISION Study group of Jikei University Kashiwa Hospital