Efficacy, Safety, and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia - Pediatric HeFH Study

• Conditions: Adolescent (age >=10 and <=17 years) subjects with Heterozygous Familial Hypercholesterolemia (HeFH).; MedDRA version: 7.0Level: LLTClassification code 10057099

• Registration Number: EUCTR2004-002627-40-AT
• Lead Sponsor: Schering-Plough Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-24
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1.Adolescent (age >10 and <17 years) boys and postmenarchal girls, > Tanner Stage II, body weight >40 kg, and above 10th percentile
2.Subjects on a diet in accordance with AAP guidelines for > 8 weeks (prior to V1) with the following:
A.Genotype-confirmed HeFH and LDL-C >159 mg/dL and <400 mg/dL OR
B.One of the following clinical criteria:
a)LDL-C >159 mg/dL and <400 mg/dL with a biological parent who has genotype-confirmed HeFH and a historical untreated LDL-C of >159 mg/dL
b)LDL-C >159 mg/dL and <400 mg/dL with a biological parent who has an untreated LDL-C of >210 mg/dL without a disorder known to cause secondary elevation of LDL-C.
c)LDL-C values >189 mg/dL and <400 mg/dL and a family history of hypercholesterolemia c/w autosomal dominant transmission.
d)LDL-C >159 mg/dL and <400 mg/dL with tendinous xanthomas, in the absence of a disorder known to cause secondary elevation of LDL-C.
3.Fasting TG <350 mg/dL at Visit 1 and Visit 2.
4.On a diet in accordance with AAP guidelines for > 13 weeks prior to the qualifying lipid determination at Visit 2.
5.Liver function tests: ALT (SGPT) and AST (SGOT), must be < 1.5 times ULN.
6.CPK must be < 1.5 times ULN.
7.Sexually active females must practice medically acceptable birth control

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subjects diagnosed with delayed puberty.
•Subjects with known hypersensitivity or any contraindication to simvastatin or ezetimibe.
•Known presence of an Apo B gene mutation with confirmed absence of an LDL–receptor mutation in either allele.
•Females pregnant, intending pregnancy, or nursing
•History of mental instability, treatment (past or present) for severe psychiatric illness that will interfere with study participation (investigator’s discretion)
•Excessive alcohol consumption or history of alcohol or drug abuse within the past 2 years (case by case)
•Underlying disease limiting life span <1 year
•Any investigational drugs within 30 days of study entry (V1)
•Participation in other clinical study (unless permitted by sponsor)
•Staff or personnel directly involved with this study
•Family members of the investigational study staff
•Any other condition that may interfere with optimal participation in the study (investigator’s d discretion)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified