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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00529178

Enrollment

232

Registered

2007-09-14

Start date

2002-12-31

Completion date

2005-03-31

Last updated

2011-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

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.

Interventions

DRUGPravastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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or gastrointestinal disease, or uncontrolled hypertension * Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol

Design outcomes

Primary

Measure	Time frame
serum LDL-C	at week 12
ALT value	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026