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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00529178
• Collaborator: (none)
• Enrollment: 232
• Duration (Months): 27

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: Pravastatin	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 232 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Dec 1, 2002
• Actual Primary Completion Date: Mar 1, 2005
• Actual Study Completion Date: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

1. serum LDL-C [at week 12]

2. ALT value []

Secondary Outcome Measures

1. change in HDL-C, TC and TG [at week 12]

2. clinical symptoms related to acute hepatic injury []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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• Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00529178
• Other Study ID Numbers: CV123-246
• First Posted: Sep 14, 2007
• Last Update Posted: Apr 25, 2011
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Liver Diseases; Hypercholesterolemia; Pravastatin

Study Results

No Results Posted as of Apr 25, 2011