Status:
COMPLETED
Atorvastatin Three Year Pediatric Study
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Familial Hypercholesterolemia
Eligibility:
All Genders
6-15 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in pediatric subjec...
Eligibility Criteria
Inclusion
- Heterozygous familial hypercholesterolemia, ages 6-15, LDL greater than 4 mmol/l
Exclusion
- Active liver disease or hepatic dysfunction, or persistent elevations of serum transaminases exceeding three times the upper limit of normal (ULN).
- Female of childbearing potential who is not using adequate contraceptive measures or any female who is pregnant or breastfeeding. Any female who becomes pregnant during study participation will be immediately discontinued from treatment and counseled appropriately about the in utero exposure.
- Known hypersensitivities to HMG-CoA reductase inhibitors
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT00827606
Start Date
March 1 2009
End Date
October 1 2013
Last Update
February 21 2021
Active Locations (40)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
3
University of Florida
Gainesville, Florida, United States, 32608
4
Johns Hopkins University
Baltimore, Maryland, United States, 21287