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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00844402 |
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Date of registration:
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13/02/2009 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis
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Scientific title:
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Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00844402 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Austria
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Contacts
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Name:
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Michael Trauner, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Graz, Department of Internal Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypercholesterolemia
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Primary Biliary Cirrhosis
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Intervention(s)
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Drug: Atorvastatin
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Primary Outcome(s)
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Low-density lipoprotein cholesterol (LDL-C)
[Time Frame: week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60]
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Secondary Outcome(s)
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AST, ALT, CK, PZ, AT, albumin, creatinine, blood cell count
[Time Frame: week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60]
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Intima-media thickness of the common carotid artery (IMT), vascular wall stiffness (stiffness index SI), flow-mediated dilation of the brachial artery (FMD)
[Time Frame: week 0, 48]
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Total cholesterol, triglycerides, VLDL-C, HDL-C, lipid profile, hs-CRP, AP, GGT, bilirubin, bile acids, immunoglobins
[Time Frame: week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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