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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Pravastatin

Criteria

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• Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol