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Completed

NCT Number: NCT00867165

Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)

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.

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Key information

Conditions

Primary Hypercholesterolemia

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 with a LDL-C of >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.

Treatment and study plan

ezetimibe

Drug

oral tablets: ezetimibe 10 mg once daily for 12 weeks

Other names: SCH 58235, MK-0653, Zetia

Placebo

Drug

oral tablets: placebo to match ezetimibe 10 mg; administered once daily during the 5-week, single-blind, placebo run-in and diet stabilization period and 12-week double-blind treatment period

Primary outcomes

  1. Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12

    Time frame: Baseline and Week 12

    Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).

Secondary outcomes

  1. Percentage Change From Baseline in Total Cholesterol (TC) at Week 12

    Time frame: Baseline and Week 12

    Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration.

  2. Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12

    Time frame: Baseline and Week 12

    Serum Apo B measured at baseline and after 12 weeks of study drug administration.

  3. Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12

    Time frame: Baseline and Week 12

    Serum HDL-C levels measured by photometry after precipitation at baseline and after 12 weeks of study drug administration.

  4. Percentage Change From Baseline in Non-HDL-C at Week 12

    Time frame: Baseline and Week 12

    Serum Non-HDL-C calculated at baseline and after 12 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.

  5. Percentage Change From Baseline in Triglycerides (TG) at Week 12

    Time frame: Baseline and Week 12

    Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug.

  6. Percent Change From Baseline in LDL-C at Week 2

    Time frame: Baseline and Week 2

    Serum LDL-C levels calculated at baseline and after 2 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).

  7. Percent Change From Baseline in LDL-C at Week 4

    Time frame: Baseline and Week 4

    Serum LDL-C levels calculated at baseline and after 4 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).

  8. Percent Change From Baseline in LDL-C at Week 8

    Time frame: Baseline and Week 8

    Serum LDL-C levels calculated at baseline and after 8 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).

  9. Percentage Change From Baseline in TC at Week 2

    Time frame: Baseline and Week 2

    Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.

  10. Percentage Change From Baseline in TC at Week 4

    Time frame: Baseline and Week 4

    Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.

  11. Percentage Change From Baseline in TC at Week 8

    Time frame: Baseline and Week 8

    Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.

  12. Percentage Change From Baseline HDL-C at Week 2

    Time frame: Baseline and Week 2

    Serum HDL-C levels measured by photometry after precipitation at baseline and after 2 weeks of study drug administration.

  13. Percentage Change From Baseline HDL-C at Week 4

    Time frame: Baseline and Week 4

    Serum HDL-C levels measured by photometry after precipitation at baseline and after 4 weeks of study drug administration.

  14. Percentage Change From Baseline HDL-C at Week 8

    Time frame: Baseline and Week 8

    Serum HDL-C levels measured by photometry after precipitation at baseline and after 8 weeks of study drug administration.

  15. Percentage Change From Baseline in Non-HDL-C at Week 2

    Time frame: Baseline and Week 2

    Serum Non-HDL-C calculated at baseline and after 2 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.

  16. Percentage Change From Baseline in Non-HDL-C at Week 4

    Time frame: Baseline and Week 4

    Serum Non-HDL-C calculated at baseline and after 4 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.

  17. Percentage Change From Baseline in Non-HDL-C at Week 8

    Time frame: Baseline and Week 8

    Serum Non-HDL-C calculated at baseline and after 8 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.

  18. Percentage Change From Baseline in TG at Week 2

    Time frame: Baseline and Week 2

    Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.

  19. Percentage Change From Baseline in TG at Week 4

    Time frame: Baseline and Week 4

    Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.

  20. Percentage Change From Baseline in TG at Week 8

    Time frame: Baseline and Week 8

    Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.

  21. Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12

    Time frame: Baseline and Week 12

    Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration.

  22. Percentage Change From Baseline in TC:HDL-C Ratio at Week 2

    Time frame: Baseline and Week 2

    Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.

  23. Percentage Change From Baseline in TC:HDL-C Ratio at Week 4

    Time frame: Baseline and Week 4

    Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.

  24. Percentage Change From Baseline in TC:HDL-C Ratio at Week 8

    Time frame: Baseline and Week 8

    Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.

  25. Percentage Change From Baseline in TC:HDL-C Ratio at Week 12

    Time frame: Baseline and Week 12

    Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.

  26. Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2

    Time frame: Baseline and Week 2

    Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.

  27. Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4

    Time frame: Baseline and Week 4

    Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.

  28. Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8

    Time frame: Baseline and Week 8

    Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.

  29. Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12

    Time frame: Baseline and Week 12

    Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.

  30. Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12

    Time frame: Baseline and Week 12

    Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration

  31. Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4

    Time frame: Baseline and Week 4

    Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration.

  32. Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12

    Time frame: Baseline and Week 12

    Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration.

  33. Percent Change From Baseline in Sitosterol at Week 2

    Time frame: Baseline and Week 2

    Plasma sitosterol measured at baseline and after 2 weeks of study drug administration.

  34. Percentage Change From Baseline in Sitosterol at Week 4

    Time frame: Baseline and Week 4

    Plasma sitosterol measured at baseline and after 4 weeks of study drug administration.

  35. Percentage Change From Baseline in Sitosterol at Week 8

    Time frame: Baseline and Week 8

    Plasma sitosterol measured at baseline and after 8 weeks of study drug administration.

  36. Percentage Change From Baseline in Sitosterol at Week 12

    Time frame: Baseline and Week 12

    Plasma sitosterol measured at baseline and after 12 weeks of study drug administration.

  37. Percentage Change From Baseline in Campesterol at Week 2

    Time frame: Baseline and Week 2

    Plasma campesterol measured at baseline and after 2 weeks of study drug administration.

  38. Percentage Change From Baseline in Campesterol at Week 4

    Time frame: Baseline and Week 4

    Plasma campesterol measured at baseline and after 4 weeks of study drug administration.

  39. Percentage Change From Baseline in Campesterol at Week 8

    Time frame: Baseline and Week 8

    Plasma campesterol measured at baseline and after 8 weeks of study drug administration.

  40. Percentage Change From Baseline in Campesterol at Week 12

    Time frame: Baseline and Week 12

    Plasma campesterol measured at baseline and after 12 weeks of study drug administration.

  41. Percentage Change From Baseline in Cholestanol at Week 2

    Time frame: Baseline and Week 2

    Plasma cholestanol measured at baseline and after 2 weeks of study drug administration.

  42. Percentage Change From Baseline in Cholestanol at Week 4

    Time frame: Baseline and Week 4

    Plasma cholestanol measured at baseline and after 4 weeks of study drug administration.

  43. Percentage Change From Baseline in Cholestanol at Week 8

    Time frame: Baseline and Week 8

    Plasma cholestanol measured at baseline and after 8 weeks of study drug administration.

  44. Percentage Change From Baseline in Cholestanol at Week 12

    Time frame: Baseline and Week 12

    Plasma cholestanol measured at baseline and after 12 weeks of study drug administration.

  45. Percentage Change From Baseline in Lathosterol at Week 2

    Time frame: Baseline and Week 2

    Plasma lathosterol measured at baseline and after 2 weeks of study drug administration.

  46. Percentage Change From Baseline in Lathosterol at Week 4

    Time frame: Baseline and Week 4

    Plasma lathosterol measured at baseline and after 4 weeks of study drug administration.

  47. Percentage Change From Baseline in Lathosterol at Week 8

    Time frame: Baseline and Week 8

    Plasma lathosterol measured at baseline and after 8 weeks of study drug administration.

  48. Percentage Change From Baseline in Lathosterol at Week 12

    Time frame: Baseline and Week 12

    Plasma lathosterol measured at baseline and after 12 weeks of study drug administration.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Efficacy and Safety Study of Ezetimibe Monotherapy in Children (Ages 6 to 10 Years) With Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) (Phase 3, Protocol No. P05522)

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 23, 2009
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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