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Efficacy and safety of ezetimibe in young children with familial hypercholesterolemia.


- candidate number2049
- NTR NumberNTR650
- ISRCTNISRCTN39762831
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR4-apr-2006
- Secondary IDsN/A 
- Public TitleEfficacy and safety of ezetimibe in young children with familial hypercholesterolemia.
- Scientific TitleA randomized double-blind placebo controlled trial to evaluate the safety and efficacy of the cholesterol absorption inhibitor, ezetimibe in a dosage of 10 mg, on plasma lipids, plant sterols and inflammatory markers in children with familial hypercholesterolemia.
- ACRONYMEZKIMO
- hypothesisEzetimibe monotherapie lowers LDL-C levels, plant sterol levels and inflammatory markers in young children with familial hypercholesterolemia.
- Healt Condition(s) or Problem(s) studiedFamilial hypercholesterolemia (FH)
- Inclusion criteria1. 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2006
- planned closingdate1-aug-2007
- Target number of participants70
- InterventionsEzetimibe 10 mg/day or placebo treatment during 4 months.
- Primary outcomePrimary endpoint will be the efficacy towards LDL-C levels and the safety of 10 mg ezetimibe.
- Secondary outcomeSecondary endpoint will be the effect of 10 mg ezetimibe on inflammatory markers and plant sterols in plasma.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. M.D. Trip
- CONTACT for SCIENTIFIC QUERIESDr. Ir. M.N. Vissers
- Sponsor/Initiator Academic Medical Center (AMC), Department of Vascular Medicine
- Funding
(Source(s) of Monetary or Material Support)
Schering-Plough, Merck Sharp & Dohme BV (MSD)
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD4-apr-2006 - 9-dec-2009


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