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OpenTrials
Completed

NCT Number: NCT00529178

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol

Treatment and study plan

Pravastatin

Drug

Primary outcomes

  1. serum LDL-C

    Time frame: at week 12

  2. ALT value

Secondary outcomes

  1. change in HDL-C, TC and TG

    Time frame: at week 12

  2. clinical symptoms related to acute hepatic injury

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Sep 14, 2007
Registry last updated
Apr 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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