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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe; Simvastatin

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.