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

Organon

Status and phase

Completed

Phase 3

Conditions

Hypercholesterolemia

Treatments

Drug: ezetimibe with simvastatin

Drug: simvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00129402

EUDRACT NUMBER:2004-002627-40 ;

DOC ID 2526810

P02579

SCH 58235 ;

Details and patient eligibility

About

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.

Full description

This study consisted of 3 distinct periods. In Period 1, subjects received daily treatment for 6 weeks as part of either the ezetimibe with simvastatin group or part of the simvastatin monotherapy group. Subjects in the ezetimibe with simvastatin group received one of three treatments: coadministration of ezetimibe 10 mg/day plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. Subjects in the simvastatin monotherapy group received one of three treatments: ezetimibe placebo plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. The primary and key secondary efficacy analysis were based on the evaluations performed during Period 1 and were presented as data for subjects pooled from either the ezetimibe with simvastatin treatment groups compared with data for subjects pooled from the simvastatin monotherapy treatment groups.

In Period 2, subjects received ezetimibe 10 mg/day plus simvastatin 40 mg/day or ezetimibe placebo plus simvastatin 40 mg/day for 27 additional weeks maintaining the same treatment assignment (coadministration vs monotherapy) as in Period 1.

In Period 3, all subjects received ezetimibe 10 mg/day plus open-label simvastatin daily for 20 weeks.

Enrollment

248 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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.