The Effect of UrsodeoXyCholicacid (UDCA) and ezetimibe on total faecal steRol ExcreTion and plasma lipid lEvels

Completed

• Conditions: Familial hypercholesterolemia; 10019806; 10013317

• Registration Number: NL-OMON47926
• Lead Sponsor: Academisch Medisch Centrum (AMC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Hypercholesterolemia
Aged 18 years or older
LDL > 2.6 mmol/L

Exclusion Criteria

* Medical, surgical, laboratory or other conditions, which in the judgment of
the Physician Investigator would make the subject unsuitable for enrollment, or
potentially interfere with subject participation or completion of the study, *
Suffering from an inflammatory bowel disease, e.g. Crohn*s disease or
ulcerative colitis., * Suffering from gall stones or another biliary disease.,
* Suffering diabetes mellitus (type I or II)., * Recent history of, or current
drug or alcohol abuse, * AST or ALT levels > 2 x ULN, * Unable or unwilling to
comply with the protocol requirements or deemed by the investigator to be unfit
for the study., * Presence of contra indications for the use of UDCA and
ezetimibe (see SPC), * Use of lipid lowering drugs such as the following:, o
Statins and fibrates unless on a stable dose for at least 3 months prior to
screening, o Use of nicotinic acid or derivates of nicotinic acid within 4
weeks prior to screening, o Use of cholestyramine or colestipol, * Use of other
drugs such as the following:, o Ciclosporine, o Antacids containing aluminium
hydroxide or aluminium oxide, * Likely to leave the study before its completion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main endpoint is the total faecal sterol concentration (faecal neutral sterol<br /><br>concentration (FNS) + faecal bile acid concentration).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint is plasma lipid profile/composition: LDL-c, HDL-c, TG, apoB,<br /><br>apoA1.</p><br>