Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease

A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine the Efficacy and Safety of Pravastatin 80 mg Administered Once Daily to Hypercholesterolemic Subjects With Chronic, Well Compensated Liver Disease

To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to placebo.

Inclusion Criteria:

• Chronic, well-compensated stable liver
• Hypercholesterolemia

Exclusion Criteria:

• Signs or symptoms of ascites, jaundice, or cirrhosis with a Child-Pugh Score > 5
• History of disorders affecting serum bilirubin levels, more than 1 chronic liver disease, significant endocrine, renal, or gastrointestinal disease, or uncontrolled hypertension
• Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol