Phase 3
N=248
Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00129402 ↗Enrolled (actual)
248
Serious AEs
1.7%
Results posted
Feb 2010
Primary outcome: Primary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) — -49.45; -34.43 percent change — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ezetimibe with simvastatin (Drug); simvastatin (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) |
-49.45; -34.43 | <0.01 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (TC) |
-38.23; -26.28 | <0.01 sig |
| SECONDARY Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C) |
-46.84; -32.68 | <0.01 sig |
| SECONDARY Percent Change From Baseline in Triglycerides (TG) |
-16.56; -12.28 | .48 |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (Apo B) |
-38.92; -26.69 | <0.01 sig |
| SECONDARY Percent Change From Baseline in HDL-C |
6.58; 6.47 | .95 |
Summary
This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with Heterozygous Familial Hypercholesterolemia.
Eligibility Criteria
Inclusion Criteria
- Adolescent (ages 10 - 17 years) boys or girls weighing at least 88 lbs (40 kg).
- Subjects must have high cholesterol (low density lipoprotein cholesterol [LDL-C] more than 159 mg/dL or 4.1 mmol/L) and a family history of high cholesterol.
Exclusion Criteria
- Subjects diagnosed with delayed puberty.
- Subjects who are sensitive to simvastatin and/or ezetimibe.
- Subjects who drink alcohol excessively or who have a history of alcohol or drug abuse within the past 2 years.
- Subjects who are known to be HIV positive, are undergoing LDL apheresis or plasma apheresis, or have had a partial ileal bypass.
Data sourced from ClinicalTrials.gov (NCT00129402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.