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

Conditions: Gallstone disease
MedDRA version: 8.1Level: LLTClassification code 10020667Term: Hyperlipidemia

Registration Number: EUCTR2006-001972-19-SE

Lead Sponsor: Hanns-Ulrich Marschall

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

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
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- relative changes in total cholesterol, LDL-C, HDL-C<br>- relative changes in TG<br>- relative changes in Apo A1, Apo B, in Lp(A)<br>;Primary end point(s): - relative changes in hepatic basolateral transport protein MRP4<br>- relative changes in hepatic apical transport proteins BSEP, MDR3, MRP2, NPC1L1<br>- relative changes in expression levels of UGT1A1<br><br>

Secondary Outcome Measures