- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00529178
Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease
April 12, 2011 updated by: Bristol-Myers Squibb
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
232
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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- Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum LDL-C
Time Frame: at week 12
|
at week 12
|
ALT value
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in HDL-C, TC and TG
Time Frame: at week 12
|
at week 12
|
clinical symptoms related to acute hepatic injury
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Primary Completion (Actual)
March 1, 2005
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
September 13, 2007
First Submitted That Met QC Criteria
September 13, 2007
First Posted (Estimate)
September 14, 2007
Study Record Updates
Last Update Posted (Estimate)
April 25, 2011
Last Update Submitted That Met QC Criteria
April 12, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Liver Diseases
- Hypercholesterolemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Pravastatin
Other Study ID Numbers
- CV123-246
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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