EUCTR2006-001972-19-SEActive, not recruitingNot Applicable
Study of atorvastatin and fenofibrate mediated effects on the metabolism and hepatic excretion of biliary compounds in gallstone patients.
Hanns-Ulrich Marschall0 sites30 target enrollmentStarted: December 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Age25 to 80 years
- •SexMales, pre-, and post-menopausal females
- •Diagnosis Patients eligible to cholecystectomy for gallstone disease
- •Consent Patients should have given their written consent to participate in this study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Active liver disease, defined as AST or ALT = 3 ULN
- •Partial ileal bypass
- •Inflammatory bowel disease
- •Chronic renal failure
- •Other serious disease
- •Known hypersensitivity to fenofibrate or atorvastatin
- •Patients who will not comply with the protocol.
Investigators
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