Efficacy and safety of statin treatment for hypercholesterolemia with chronic liver disease

UMIN ID: UMIN000002011

Registered date:27/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: chronic liver disease
• Date of first enrollment: 2009/06/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Pitavastatin 1-2mg/day

Outcome(s)

• Primary Outcome: 1.Change in AST, ALT, gammaGTP, ALP(for NAFLD, NASH) 2.Change in HCV RNA(for hepatitis C)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: (1)Contraindication or relative contraindication of pitavastatin calcium. -Hypersensitivity for pitavastatin calcium -Serious hepatic disorder or biliary atresia -Receiving ciclosporin -Pregnant women, women suspected of being pregnant, or lactating women -Patients receiving fibrates who have abnormal laboratory test values about renal function (2)Women hoping to become pregnant during the study (3)Drug abuse, alcoholism (4)Patients judged to be inappropriate by the attending doctor

Related Information

• Primary Sponsor: The Jikei University School of Medicine, Kashiwa Hospital
• Source(s) of Monetary Support: The Jikei University School of Medicine, Kashiwa Hospital