familial hypercholesterolemia
Conditions
Interventions
Trade Name: Atorvastatin
Product Name: Atorvastatin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ATORVASTATIN
CAS Number: 134523-00-5
Concentration unit: mg milligram(s)
Concentration
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: inclusion criteria for FH: • Age 18-75 years • written consent • positive Simon Broome criteria (possible and definitely) • no lipid-lowering therapy in the 6 weeks before inclusion inclusion criteria control subjects: • Age 18-75 years • written consent • Patients without disorder of LDL metabolism, proven by=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Active Liver-disease or impairment of liver function with GOT and/or GPT > 2 x value of the Upper Limit of Normal= (ULN) 2. mid-level or severe renal insufficiency 3. TSH not im reference range 4. uncontrolled aterial hypertension: Diastolic RR 105 mmHg and/or systolic RR 160 mmHg 5. lipid-lowering therapy within the last 6 weeks before the screening 6. alcohol abuse, smoking or other drug abuse 7. blood donation within the last 6 weeks before the screening 8. Patients with a adverse acute disease 9. HbA1c > 6.5% 10. Other important striking internistic diseases, which may alter the lipidmetabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to develope a mathematical model describing the lipoproteins of low density (LDL) in healthy probands and patients with familial hypercholesterinemia based on clinical data;Secondary Objective: Secondary objectives are to characterize the influence of statin on LDL metabolism and to compare healthy probands and patients with familial hypercholesterinemia.;Primary end point(s): Apolipoprotein B (ApoB), triglyceride (TG), free cholesteryl (FC) and cholesteryl ester (CE) distribution in the LDL and their subfractions;Timepoint(s) of evaluation of this end point: each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): activity of the following enzyms: Lecithin—cholesterol acyltransferase (LCAT), Cholesterylester transfer protein (CETP), Phospholipid transfer protein (PLTP), Lipoprotein-associated phospholipase A2 (LP-PLA2) concentration of the lipids: TG, CE, FC and phospholipids (PL) in all lipoprotein-subfractions concentration of the apolipoproteins: Apolipoprotein-A1, Apolipoprotein-A2, Apolipoprotein B-100, Apolipoprotein-E, Apolipoprotein-CII, Apolipoprotein-CIII and Lipoprotein Lp(a) in all lipoprotein subfractions, HDL functionality;Timepoint(s) of evaluation of this end point: each visit | — |
Countries
Germany
Contacts
Public ContactMartin Jansen
Universitätsklinikum Freiburg Institut für klinische Chemie und Laboratoriumsmedizin
Outcome results
None listed