Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
272 participants
INTERVENTIONAL
2009-03-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Atorvastatin
All subjects will be treated with atorvastatin
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
6 Years
15 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
MEDPACE Clinical Pharmacology Unit
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cliniques Universitaires Saint-Luc / Pediatrie generale
Brussels, , Belgium
Universitaire Ziekenhuizen Leuven / Center for Metabolic Diseases
Leuven, , Belgium
Clinique des Maladies Lipidiques de Quebec
Québec, Quebec, Canada
Clinique des maladies lipidiques de Quebec Inc
Sainte-Foy, Quebec, Canada
Charite Campus Virchow-Klinikum
Berlin, , Germany
Augenaerztliche Gemeinschaftspraxis
Freiburg im Breisgau, , Germany
1st Pediatrics Clinic , University of Athens, Agia Sofia Hospital
Athens, , Greece
Semmelweis Medical University
Budapest, , Hungary
Fejer Megyei Szent Gyorgy Korhaz
Székesfehérvár, , Hungary
Dipartimento di Medicina Clinica e delle Patologie Emergenti-University Hospital of Palermo
Palermo, , Italy
Dipartimento di Clinica e Terapia Medica, Università degli Studi di Roma La Sapienza
Roma, , Italy
Rikshospitalet Lipidklinikken
Oslo, , Norway
Poradnia Chorob Metabolicznych
Bydgoszcz, , Poland
Klinika Chorob Metabolicznych
Warsaw, , Poland
Hospital de la Concepcion
San Germán, , Puerto Rico
Moscow State Healthcare Institution 'Morozovskaya Children's City Clinical Hospital'
Moscow, , Russia
Autonomous Non-Profit Organization Medical Center 21 Century
Saint Petersburg, , Russia
Saint-Petersburg State Pediatric Medical Academy
Saint Petersburg, , Russia
Saint-Petersburg State Healthcare Institution "Children's Polyclinic #35"
Saint Petersburg, , Russia
Metabolicka ambulancia, 2. Detská klinika Lekárskej fakulty Univerzity Komenského
Bratislava, , Slovakia
Detska fakultna nemocnica Kosice-old
Košice, , Slovakia
Detska fakultna nemocnica Kosice
Košice, , Slovakia
Lipmet, s.r.o.
Poprad, , Slovakia
Fakultna nemocnica Trencin
Trenčín, , Slovakia
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital de Merida
Mérida, Badajoz, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, , Spain
Dr. med. Jean-Marc Nuoffer
Ch-3010 Bern, , Switzerland
Hacettepe University Medical Faculty. Department of Pediatrics. Nutrition and Metabolism Unit
Ankara, , Turkey (Türkiye)
Gazi University, Medical Faculty
Ankara, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Countries
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References
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Langslet G, Breazna A, Drogari E. A 3-year study of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2016 Sep-Oct;10(5):1153-1162.e3. doi: 10.1016/j.jacl.2016.05.010. Epub 2016 Jun 7.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2008-006130-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A2581173
Identifier Type: -
Identifier Source: org_study_id
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