Phase 3
N=138
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
Primary Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00867165 ↗Enrolled (actual)
138
Serious AEs
1.5%
Results posted
May 2013
Primary outcome: Primary: Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 — -27.70; -0.95 Percent Change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ezetimibe (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 |
-27.70; -0.95 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Total Cholesterol (TC) at Week 12 |
-20.74; 0.19 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12 |
-21.66; -1.42 | <0.001 sig |
| SECONDARY Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12 |
2.11; 1.41 | 0.807 |
| SECONDARY Percentage Change From Baseline in Non-HDL-C at Week 12 |
-25.47; 0.28 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Triglycerides (TG) at Week 12 |
-6.23; 8.44 | 0.021 sig |
| SECONDARY Percent Change From Baseline in LDL-C at Week 2 |
-24.75; 0.23 | <0.001 sig |
| SECONDARY Percent Change From Baseline in LDL-C at Week 4 |
-26.93; -2.99 | <0.001 sig |
| SECONDARY Percent Change From Baseline in LDL-C at Week 8 |
-27.22; 0.49 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in TC at Week 2 |
-18.69; 1.40 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in TC at Week 4 |
-20.57; -0.29 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in TC at Week 8 |
-20.84; 0.54 | <0.001 sig |
| SECONDARY Percentage Change From Baseline HDL-C at Week 2 |
0.01; 0.96 | 0.733 |
| SECONDARY Percentage Change From Baseline HDL-C at Week 4 |
0.86; 0.33 | 0.863 |
| SECONDARY Percentage Change From Baseline HDL-C at Week 8 |
1.41; -0.52 | 0.501 |
| SECONDARY Percentage Change From Baseline in Non-HDL-C at Week 2 |
-22.54; 1.64 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Non-HDL-C at Week 4 |
-24.94; -0.33 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Non-HDL-C at Week 8 |
-25.41; 1.14 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in TG at Week 2 |
-3.90; 5.83 | 0.137 |
| SECONDARY Percentage Change From Baseline in TG at Week 4 |
-5.54; 9.65 | 0.005 sig |
| SECONDARY Percentage Change From Baseline in TG at Week 8 |
-9.99; -1.38 | 0.149 |
| SECONDARY Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12 |
1.80; 3.71 | 0.373 |
| SECONDARY Percentage Change From Baseline in TC:HDL-C Ratio at Week 2 |
-17.21; 2.56 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in TC:HDL-C Ratio at Week 4 |
-19.36; 1.48 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in TC:HDL-C Ratio at Week 8 |
-20.07; 3.41 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in TC:HDL-C Ratio at Week 12 |
-21.09; 1.20 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2 |
-23.35; 1.15 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4 |
-25.72; -0.57 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8 |
-26.43; 2.87 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12 |
-28.01; 0.34 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12 |
-22.16; -2.87 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4 |
10.00; 56.11 | 0.116 |
| SECONDARY Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12 |
9.35; -7.92 | 0.382 |
| SECONDARY Percent Change From Baseline in Sitosterol at Week 2 |
-50.20; -0.59 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Sitosterol at Week 4 |
-58.82; -0.30 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Sitosterol at Week 8 |
-61.59; -0.57 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Sitosterol at Week 12 |
-60.65; 2.09 | 0.001 sig |
| SECONDARY Percentage Change From Baseline in Campesterol at Week 2 |
-53.87; -4.38 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Campesterol at Week 4 |
-62.27; -4.28 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Campesterol at Week 8 |
-66.79; -4.19 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Campesterol at Week 12 |
-67.59; -2.92 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Cholestanol at Week 2 |
-25.44; -7.09 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Cholestanol at Week 4 |
-27.40; -1.79 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Cholestanol at Week 8 |
-29.19; -0.44 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Cholestanol at Week 12 |
-28.71; 3.42 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Lathosterol at Week 2 |
34.07; 14.06 | 0.001 sig |
| SECONDARY Percentage Change From Baseline in Lathosterol at Week 4 |
33.02; 6.73 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Lathosterol at Week 8 |
35.87; -0.82 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Lathosterol at Week 12 |
36.62; 12.57 | <0.001 sig |
Summary
The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children >=6 to <=10 years old with primary hypercholesterolemia. The study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The safety of ezetimibe in this subject population will also be evaluated.
Eligibility Criteria
Inclusion Criteria
- Each subject may be of either sex and of any race/ethnicity, and must be >=6 and 159mg/dL
- Each subject's parent/guardian must be willing to give written informed consent on his/her behalf.
Exclusion Criteria
Each subject must not:
- Have known hypersensitivity or any contraindication to ezetimibe.
- Have use of any investigational drugs within 30 days of study entry.
- Be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
- Be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing
- Have known congenital cardiac disorder.
- Have documented or laboratory values consistent with homozygous familial hypercholesterolemia (HoFH).
- Be known to be human immunodeficiency virus (HIV) positive.
Data sourced from ClinicalTrials.gov (NCT00867165). 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.