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

Bristol-Myers Squibb232 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

232

Conditions

Hypercholesterolemia

Interventions

PravastatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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or gastrointestinal disease, or uncontrolled hypertension * Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol

Outcomes

Primary Outcomes

serum LDL-C

Time frame: at week 12

ALT value

Secondary Outcomes

change in HDL-C, TC and TG

Time frame: at week 12

clinical symptoms related to acute hepatic injury

Data from ClinicalTrials.gov

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