None listed
Conditions
Interventions
Trade Name: Ezetrol
Product Name: Ezetimibe
Pharmaceutical Form: Tablet
INN or Proposed INN: Ezetimibe
Concentration unit: mg milligram(
Sponsors
Schering-Plough Research Institute, A Division of Schering Corporation,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Each subject may be of either sex and of any race/ethnicity, and must be =6 and =10 years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial or nonfamilial) despite being on a lipid-lowering diet for at least 3 months 2. Any subject meeting at least one of the following clinical criteria items, a-e below, will be considered to have heterozygous familial hypercholesterolemia: a. genotype-confirmed HeFH with written documentation of the genetic diagnosis prior to or at the time of screening & LDL-C >159 mg/dL(4.1 mmol/L) & 159 mg/dL (4.1 mmol/L) & 159 mg/dL c. LDL-C >159 mg/dL (4.1 mmol/L) & 159 mg/dL (4.1 mmol/L) & 189 mg/dL (4.9 mmol/L) & 159mg/dL (4.1 mmol/L) and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Each subject must not: 1. have known hypersensitivity or any contraindication to ezetimibe 2. have BMI above the 97th percentile for age & sex (using accepted standards, such as Centers for Disease Control (CDC) & Prevention charts and/or World Health Organization (WHO) 3. have a height below the 3rd percentile for age & sex (using accepted standards) 4. be in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study 5. have an underlying disease likely to limit life span to less than 1 year 6. have use of any investigational drugs within 30 days of study entry 7. have participation in any other clinical study, unless permission is given by this sponsor 8. be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial 9. be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing 10. be a female of child-bearing potential who will not abstain from sex or use a medically acceptable method of birth control in the opinion of the investigator Exclusionary Concomitant Illness: Each subject must not: 1. have known congenital cardiac disorder 2. have any cardiac disorder that may limit participation in the study 3. have documented or laboratory values consistent with homozygous familial hypercholesterolemia (HoFH) 4. have disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease, anorexia nervosa, & degenerative disease that would limit study evaluation or participation 5. have Type 1 diabetes mellitus 6. have Type 2 diabetes mellitus 7. have uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins 8. be on unstable thyroid hormone replacement therapy with TSH levels outside the normal range 9. have known clinically significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease 10. have fasting plasma triglyceride that is >150 mg/dL (>1.69 mmol/L) at Visit 1 and/or Visit 3 11. have serum creatinine = 2.0 mg/dL 12. have active or chronic hepatic or biliary disease 13. have AST and/or ALT >1.5 times the upper limit of normal (ULN) of the central laboratory reference range 14. have blood creatine phosphokinase or creatine kinase (CPK) >1.5 times the ULN of the central laboratory reference range 15. be known to be HIV positive 16. have known coagulopathy 17. be undergoing LDL apheresis or plasma apheresis 18. have a history of a partial ileal bypass or disease that affects significant function of ileum 19. have a history of mental instability, or be an individual who has been treated, or is being treated, for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the effect of ezetimibe 10mg/day compared to placebo on the reduction of LDL-C from baseline to 12 weeks of treatment in children =6 to =10 years old with primary hypercholesterolemia (HeFH and nonfamilial);Primary end point(s): The percent change from baseline in LDL-C to 12 weeks in the ezetimibe group compared to the placebo group.; Secondary Objective: Key secondary objective: Determine effect of ezetimibe 10mg/day compared to placebo on TC, Apo B, HDL-C, non-HDL-C, & TG from baseline (BL) to 12 weeks of treatment Other secondary objectives: Determine effect of ezetimibe 10mg/day compared to placebo on: -LDL-C, TC, HDL-C, non-HDL-C, TG, and ratios LDL-C:HDL-C and TC:HDL-C from baseline to 2, 4 and 8 weeks of treatment -apolipoprotein A1 (Apo A1), and ratios of LDL-C:HDL-C, TC:HDL-C, and Apo B: Apo A1 from baseline to 12 weeks of treatment -Plasma hs-CRP from BL to 4 & 12 weeks of treatment -Plasma plant sterols/stanols, sitosterol, campesterol, and cholestanol & lathosterol from BL to 2, 4, 8, & 12 weeks of treatment Determine safety of ezetimibe 10 mg/day as assessed by AEs, physical examinations, lab parameters (chemistry, hematology, urinalysis, & steroid hormone levels), & effects on liver and muscle | — |
Countries
France, Greece, Italy, Netherlands
Outcome results
None listed