Contact information
Type
Scientific
Primary contact
Dr M.D. Trip
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Cardiology
F4- 109
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5665882 or 020-5669111
m.d.trip@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
EZKIMO
Study hypothesis
Ezetimibe monotherapy lowers low density lipoprotein-cholesterol (LDL-C) levels, plant sterol levels and inflammatory markers in young children with familial hypercholesterolemia (FH).
Ethics approval
Not provided at time of registration
Study design
Randomized, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Familial hypercholesterolemia (FH)
Intervention
Ezetimibe 10 mg/day versus placebo treatment for 4 months
Intervention type
Drug
Phase
Not Specified
Drug names
Ezetimibe
Primary outcome measures
Primary endpoint will be the efficacy towards LDL-C levels and the safety of 10 mg ezetimibe.
Secondary outcome measures
Secondary endpoint will be the effect of 10 mg ezetimibe on inflammatory markers and plant sterols in plasma.
Overall trial start date
01/08/2006
Overall trial end date
01/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female
2. Aged 8-14 years
3. Heterozygous familial hypercholesterolemia defined as:
a. Molecular diagnosis of FH AND LDL-C above 95th percentile for age and sex (LDL-C >3.88 mmol/l) despite a lipid-lowering diet for at least 3 months
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
c. One parent with either a clinical or molecular diagnosis of FH
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
70
Participant exclusion criteria
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 mmHg or diastolic >100 mmHg)
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, aspartate aminotransferase or alanine aminotransferase (ASAT or ALAT), must be <1.5 times the upper limit of normal (ULN) using the central laboratory reference range
14. Creatinine clearance levels must be <1.5 times the ULN using the central laboratory reference range
Recruitment start date
01/08/2006
Recruitment end date
01/08/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Funders
Funder type
Industry
Funder name
Merck Sharp and Dohme BV (MSD)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Schering-Plough
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary