Atorvastatin Three Year Pediatric Study

Completed · Phase 3

Conditions studied: Familial Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT00827606

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

272

Starts

2009-03-01

Expected to finish

2013-10-01

Last updated by the study team

2021-02-21

Who can join

Age: 6 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Heterozygous familial hypercholesterolemia, ages 6-15, LDL greater than 4 mmol/l

You may not qualify if…

• 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

Where it is running

• 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 German, 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

Full record on ClinicalTrials.gov

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