Atorvastatin Three Year Pediatric Study

NCT00827606

Last updated date
Study Location
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Contact
1-800-718-1021

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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

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Familial HypercholesterolemiaAtorvastatin Three Year Pediatric Study
NCT00827606
  1. Phoenix, Arizona
  2. Washington, District of Columbia
  3. Gainesville, Florida
  4. Balitmore, Maryland
  5. Baltimore, Maryland
  6. Baltimore, Maryland
  7. Cincinnati, Ohio
  8. Philadelphia, Pennsylvania
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  12. Quebec,
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  18. Palermo,
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  27. St Petersburg,
  28. Bratislava,
  29. Kosice,
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  31. Poprad,
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  35. Santander, Cantabria
  36. Barcelona,
  37. Esplugues de Llobregat,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Atorvastatin Three Year Pediatric Study
Official Title  ICMJE A Three Year, Prospective, Open-label, Study To Evaluate Clinical Efficacy, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Familial Hypercholesterolemia
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: Atorvastatin
All subjects will be treated with atorvastatin
Intervention: Drug: atorvastatin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2013)
272
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2009)
250
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Germany,   Greece,   Hungary,   Italy,   Norway,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   Spain,   Switzerland,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00827606
Other Study ID Numbers  ICMJE A2581173
2008-006130-95 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP