Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT00844402
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00844402
Study Brief:
Protocol Section:
NCT00844402