Ezetimibe monotherapie lowers LDL-C levels, plant sterol levels and inflammatory markers in young children with familial hypercholesterolemia.
ID
Bron
Verkorte titel
Aandoening
Familial hypercholesterolemia
Ondersteuning
Merck Sharp and Dohme and
Schering Plough
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary endpoint will be the efficacy towards LDL-C levels and the safety of 10 mg ezetimibe.
Achtergrond van het onderzoek
In 70 young children with FH we will examine the safety of ezetimibe 10mg monotherapy and the efficacy on plasma lipid levels, plantsterols and inflammatory markers.
Doel van het onderzoek
Ezetimibe monotherapie lowers LDL-C levels, plant sterol levels and inflammatory markers in young children with familial hypercholesterolemia.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Ezetimibe 10 mg/day or placebo treatment during 4 months.
Publiek
P.O. Box 22660
M.D. Trip
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665882 or 020-5669111
m.d.trip@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
M.D. Trip
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665882 or 020-5669111
m.d.trip@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Males or females;
2. Aged 8-14 years;
3. Heterozygous Familial hypercholesterolemia defined as:
a. Molecular diagnosis of FH AND LDL-cholesterol above 95th percentile for age and sex (LDL-C> 3.88 mmol/L) despite a lipid-lowering diet for at least 3 months; OR
b. LDL-cholesterol above 95th percentile for age and sex (LDL-C> 3.88 mmol/L) despite a lipid-lowering diet for at least 3 months; AND
c. One parent with either a clinical or molecular diagnosis of FH.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Homozygous familial hypercholesterolemia;
2. Diseases that cause a secondary increase in LDL-C, such as diabetes mellitus, anorexia nervosa and renal, hepatic or thyroid disease;
3. Length below the 3rd percentile for age and sex;
4. Weight-compared-to-length above the 97th percentile for age and sex;
5. Serious illness in the previous three months;
6. Major surgery in the previous three months;
7. Partial ileal bypass or any gastrointestinal disease that might interfere with drug absorption;
8. Plasma triglycerides above 4.0 mmol/l;
9. Hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg);
10. Psychological disorders that might interfere with adherence to the protocol;
11. Pregnancy at baseline;
12. History of allergy or sensitivity to ezetimibe;
13. Liver function tests, ASAT or ALAT, must be < 1.5 times the upper limit of normal (ULN) using the central laboratory reference range;
14. CK levels must be <1.5 times the ULN using the central laboratory reference range.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL594 |
NTR-old | NTR650 |
Ander register | : N/A |
ISRCTN | ISRCTN39762831 |