Status:
COMPLETED
Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief 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 wi...
Detailed 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 gro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00129402
Start Date
August 1 2005
End Date
June 1 2007
Last Update
February 8 2022
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