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Atorvastatin Three Year Pediatric Study

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NCT00827606

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Phoenix Children's Hospital
Phoenix, Arizona, 85016 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Familial Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-15 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00827606
Pfizer
Completed
Atorvastatin Three Year Pediatric Study

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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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Familial Hypercholesterolemia
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)
Experimental: Atorvastatin
All subjects will be treated with atorvastatin
Intervention: Drug: atorvastatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
272
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
6 Years to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Germany,   Greece,   Hungary,   Italy,   Norway,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   Spain,   Switzerland,   Turkey,   United States
 
 
NCT00827606
A2581173
2008-006130-95 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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