NCT00827606

Atorvastatin Three Year Pediatric Study

A Three Year, Prospective, Open-label, Study To Evaluate Clinical Efficacy, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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 subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin treatment.

Conditions

• Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	atorvastatin	Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years (an 80 mg maximum daily dose is delivered by taking two 40 mg strengths, once daily)

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2009-01-23
• Last updated: 2021-02-21
• Results posted: 2015-06-02

Locations

40 sites across 15 countries: United States, Belgium, Canada, Germany, Greece, Hungary, Italy, Norway, Poland, Puerto Rico, Russia, Slovakia, Spain, Switzerland, Turkey (Türkiye)