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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529178
• Other study ID #: CV123-246
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2007
• Last updated: April 12, 2011
• Start date: December 2002
• Est. completion date: March 2005

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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• Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Liver Diseases

Intervention

Drug:
• Pravastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum LDL-C		at week 12
Primary	ALT value
Secondary	change in HDL-C, TC and TG		at week 12
Secondary	clinical symptoms related to acute hepatic injury

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm