Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)(COMPLETED)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00129402
• Date of registration: 09/08/2005
• Primary sponsor: Schering-Plough
• Public title: Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)(COMPLETED)
• Scientific title: Efficacy, Safety, and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia
• Date of first enrolment: August 2005
• Target sample size: 248
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00129402
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Argentina, Austria, Brazil, Canada, Chile, Colombia, Finland, France, Germany, Italy, Mexico, Netherlands, Norway, South Africa, Spain, United States

Key inclusion & exclusion 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.



Age minimum: 10 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypercholesterolemia

Intervention(s)

Drug: ezetimibe with simvastatin

Drug: simvastatin

Primary Outcome(s)

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [Time Frame: baseline to 6 weeks]

Secondary Outcome(s)

Percent Change From Baseline in Apolipoprotein B (Apo B) [Time Frame: baseline to 6 weeks]

Percent Change From Baseline in HDL-C [Time Frame: baseline to 6 weeks]

Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C) [Time Frame: baseline to 6 weeks]

Percent Change From Baseline in Total Cholesterol (TC) [Time Frame: baseline to 6 weeks]

Percent Change From Baseline in Triglycerides (TG) [Time Frame: baseline to 6 weeks]

Secondary ID(s)

DOC ID 2526810

EUDRACT NUMBER:2004-002627-40;

P02579

SCH 58235;

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck