Study of atorvastatin and fenofibrate mediated effects on the metabolism and hepatic excretion of biliary compounds in gallstone patients.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001972-19-SE

Enrollment

Registered

2006-12-01

Start date

2007-01-22

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallstone disease MedDRA version: 8.1 Level: LLT Classification code 10020667 Term: Hyperlipidemia

Interventions

Trade Name: Lipitor Product Name: Lipitor Pharmaceutical Form: Tablet Trade Name: Lipanthyl Product Name: Lipanthyl Product Code: C10AB05 Pharmaceutical Form: Capsule, hard

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 25 to 80 years Sex Males, 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

Exclusion criteria: Active liver disease, defined as AST or ALT = 3 ULN CPK = 10 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effects of fenofibrate and atorvastatin (i) on bile acid and bilirubin metabolism and detoxification.;Secondary Objective: - relative change in biliary oxysterols - relative changes in total cholesterol, LDL-C, HDL-C - relative changes in TG - relative changes in Apo A1, Apo B, in Lp(A) ;Primary end point(s): - relative changes in hepatic basolateral transport protein MRP4 - relative changes in hepatic apical transport proteins BSEP, MDR3, MRP2, NPC1L1 - relative changes in expression levels of UGT1A1	—

Measure

Time frame

Main Objective: To study the effects of fenofibrate and atorvastatin (i) on bile acid and bilirubin metabolism and detoxification.;Secondary Objective: - relative change in biliary oxysterols - relative changes in total cholesterol, LDL-C, HDL-C - relative changes in TG - relative changes in Apo A1, Apo B, in Lp(A) ;Primary end point(s): - relative changes in hepatic basolateral transport protein MRP4 - relative changes in hepatic apical transport proteins BSEP, MDR3, MRP2, NPC1L1 - relative changes in expression levels of UGT1A1

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026