Familial hypercholesterolemia
Conditions
Interventions
One group will receive UDCA 600 mg orally once a day, the other group will
receive a matching placebo. This will be on the background of 20 mg/day
ezetimibe.
Sponsors
Academisch Medisch Centrum (AMC)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Hypercholesterolemia Aged 18 years or older LDL > 2.6 mmol/L
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main endpoint is the total faecal sterol concentration (faecal neutral sterol concentration (FNS) + faecal bile acid concentration). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint is plasma lipid profile/composition: LDL-c, HDL-c, TG, apoB, apoA1. | — |
Countries
Netherlands
Outcome results
None listed