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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: Pravastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529178

CV123-246

Details and patient eligibility

About

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.

Enrollment: 232 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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• Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind