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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00529178
First Posted: September 14, 2007
Last Update Posted: April 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
September 13, 2007
September 14, 2007
April 25, 2011
December 2002
March 2005   (Final data collection date for primary outcome measure)
  • serum LDL-C [ Time Frame: at week 12 ]
  • ALT value
Same as current
Complete list of historical versions of study NCT00529178 on ClinicalTrials.gov Archive Site
  • change in HDL-C, TC and TG [ Time Frame: at week 12 ]
  • clinical symptoms related to acute hepatic injury
Same as current
Not Provided
Not Provided
 
Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hypercholesterolemia
Drug: Pravastatin
Not Provided
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.
 
Completed
232
March 2005
March 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00529178
CV123-246
Yes
Not Provided
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP