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

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00529178

First received: September 13, 2007

Last updated: April 12, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 13, 2007
Last Updated Date	April 12, 2011
Start Date ^ICMJE	December 2002
Primary Completion Date	March 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 13, 2007)	serum LDL-C [ Time Frame: at week 12 ] ALT value
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00529178 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 13, 2007)	change in HDL-C, TC and TG [ Time Frame: at week 12 ] clinical symptoms related to acute hepatic injury
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Hypercholesterolemia
Intervention ^ICMJE	Drug: Pravastatin
Study Arm (s)	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	232
Completion Date	March 2005
Primary Completion Date	March 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00529178
Other Study ID Numbers ^ICMJE	CV123-246
Has Data Monitoring Committee	Yes
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bristol-Myers Squibb
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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