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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pravastatin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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  • Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol

Sites / Locations

    Outcomes

    Primary Outcome Measures

    serum LDL-C
    ALT value

    Secondary Outcome Measures

    change in HDL-C, TC and TG
    clinical symptoms related to acute hepatic injury

    Full Information

    First Posted
    September 13, 2007
    Last Updated
    April 12, 2011
    Sponsor
    Bristol-Myers Squibb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00529178
    Brief Title
    Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    March 2005 (Actual)
    Study Completion Date
    March 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Bristol-Myers Squibb

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    232 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Pravastatin
    Primary Outcome Measure Information:
    Title
    serum LDL-C
    Time Frame
    at week 12
    Title
    ALT value
    Secondary Outcome Measure Information:
    Title
    change in HDL-C, TC and TG
    Time Frame
    at week 12
    Title
    clinical symptoms related to acute hepatic injury

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17668878
    Citation
    Lewis JH, Mortensen ME, Zweig S, Fusco MJ, Medoff JR, Belder R; Pravastatin in Chronic Liver Disease Study Investigators. Efficacy and safety of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease: Results of a prospective, randomized, double-blind, placebo-controlled, multicenter trial. Hepatology. 2007 Nov;46(5):1453-63. doi: 10.1002/hep.21848.
    Results Reference
    derived

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

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