Adolescent (age >=10 and <=17 years) subjects with Heterozygous Familial Hypercholesterolemia (HeFH). MedDRA version: 7.0 Level: LLT Classification code 10057099
Conditions
Interventions
Trade Name: Ezetrol
Product Name: Ezetrol
Pharmaceutical Form: Tablet
INN or Proposed INN: Ezetimibe
Concentration unit: mg milligram(s)
Sponsors
Schering-Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adolescent (age >10 and 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 159 mg/dL and 159 mg/dL b) LDL-C >159 mg/dL and 210 mg/dL without a disorder known to cause secondary elevation of LDL-C. c) LDL-C values >189 mg/dL and 159 mg/dL and 13 weeks prior to the qualifying lipid determination at Visit 2. 5. Liver function tests: ALT (SGPT) and AST (SGOT), must be =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Hypothesis- Greater % change in LDL-C at end of 6 weeks (Step 1) in Simva + Eze pooled cohort vs Simva monotherapy pooled cohor ;Primary end point(s): Percent change in LDL-C at end of 6 weeks (Step 1) in Simva + Eze pooled cohort vs Simva monotherapy pooled cohort; Secondary Objective: Key Secondary objectives: • Greater % change in TC, TG, ApoB, and HDL-C at end of 6 weeks (Step 1) in Simva + Eze pooled cohort vs. Simva monotherapy pooled cohort Other secondary Objectives: • Greater % change in LDL-C at end of 6 weeks (Step 1) in each Simva + Eze dose cohort vs. each Simva monotherapy dose cohort • Greater % change in LDL-C, TC, and ApoB at end of 33 weeks (Step 2) in Simva + Eze cohort vs. Simva monotherapy cohort • Greater proportion of subjects in Simva + Eze cohort will achieve NCEP LDL-C goal (<110) at end of 33 weeks (Step 2) vs. Simva monotherapy cohort • Coadministration of Eze 10 with Simva will be well-tolerated (including liver, muscle, and maturation) | — |
Countries
Austria, Finland, Germany, Italy, Spain
Outcome results
None listed