Status:
COMPLETED
Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis
Lead Sponsor:
Medical University of Graz
Conditions:
Primary Biliary Cirrhosis
Hypercholesterolemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Primary biliary cirrhosis (PBC) is frequently associated with hypercholesterolemia and possibly with an increased cardiovascular morbidity and mortality. Statins lower serum cholesterol levels and may...
Detailed Description
Primary biliary cirrhosis (PBC) is often associated with abnormalities in serum lipids. Hypercholesterolemia is an established risk factor for cardiovascular morbidity and mortality. Since many PBC pa...
Eligibility Criteria
Inclusion
- LDL-cholesterol \> 130 mg/dl
- Primary biliary cirrhosis (AMA positive or biopsy proven)
- Male or female gender
- Age 18-70 years
- Normal kidney function
Exclusion
- Primary biliary cirrhosis Stage III-IV (Ludwig Score)
- Liver cirrhosis
- Decompensated liver disease ( \> Child-Pugh class B, ascites, esophageal varices)
- ALT or AST \> 2x ULN
- Pregnancy or breastfeeding
- Premenopausal women without certain contraception
- Known hypersensitivity to HMG-CoA reductase inhibitors
- Current treatment with lipid-lowering agents other than atorvastatin; immunosuppressants, macrolides
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00844402
Start Date
January 1 2006
End Date
November 1 2007
Last Update
February 16 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Internal Medicine, Medical University of Graz
Graz, Austria, 8036