At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 272 enrolled
Drug / intervention
atorvastatindrug
Likely dose
atorvastatin 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Three Year, Prospective, Open-label, Study To Evaluate Clinical Efficacy, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jan 23, 2009·Updated Feb 21, 2021
In Brief
A Phase 3 clinical trial evaluating atorvastatin for Familial Hypercholesterolemia. Completed, enrolled 272 participants across 40 sites in 15 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Hypercholesterolemia
CountriesBelgium, Canada, Germany, Greece, Hungary, Italy, Norway, Poland, Puerto Rico, Russia, Slovakia, Spain, Switzerland, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartMar 2009
Primary CompletionOct 2013
TodayJul 2026
First PostedJan 23, 2009
Enrollment StartMar 1, 2009
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 17.4 years ago
Interventions
atorvastatindrug
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)