This is a randomized study to evaluate the efficacy and safety of ezetimibe taken once daily along with simvastatin compared with simvastatin taken alone in subjects ages 10 - 17 years with a family history of high cholesterol. The study duration is approximately one year.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: ezetimibe	Phase III

Ages Eligible for Study:  10 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Adolescent (age 10 - 17 years) boys or girls weighing at least 88 lbs (40 kg).
• Subjects must have high 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00129402

Wisconsin
      Marshfield Clinic, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Canada
      CHUQ - Pavillon CHUL, Sainte-Foy,  Canada; Recruiting
      Centre Cardiovasculaire de Laval, Laval,  Canada; Recruiting
Netherlands
      Academic Medical Center, Amsterdam,  Netherlands; Recruiting

Study ID Numbers:  P02579
Last Updated:  August 10, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00129402
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23