Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
07/06/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes