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

Phase 4

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00529178
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-13
• Study First Posted: 2007-09-14
• Status Verified: 2011-04
• Disposition First Submitted: 2011-04-12
• Disposition First Submitted QC: 2011-04-12
• Last Update Submitted: 2011-04-12
• Disposition First Posted: 2011-04-25
• Last Update Posted: 2011-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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• Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ALT value
serum LDL-C	at week 12

Secondary Outcome Measures

Name	Time	Method
change in HDL-C, TC and TG	at week 12
clinical symptoms related to acute hepatic injury