Atorvastatin Three Year Pediatric Study


Tracking Information

Start Date  ICMJEMarch 2009
Estimated Primary Completion DateJuly 2013   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: July 29, 2009)
  • To characterize long-term, three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) in pediatric subjects with HeFH receiving atorvastatin treatment [ Time Frame: 3 monthly visits post treatment initiation, next visit 3 months later, then every 6 months for the r ] [ Designated as safety issue: No ]
  • To characterize long-term, three year descriptive efficacy (LDL-C, TC, TG, HDL, VLDL, Apo A-1, Apo B), tolerability and safety in pediatric subjects with HeFH receiving atorvastatin treatment. [ Time Frame: 3 monthly visits post treatment initiation, next visit 3 months later, then every 6 months for the r ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: January 22, 2009)
  • To characterize long-term, three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) in pediatric subjects with HeFH receiving atorvastatin treatment [ Time Frame: 4 July 2013 ] [ Designated as safety issue: No ]
  • To characterize long-term, three year descriptive efficacy (LDL-C, TC, TG, HDL, VLDL, Apo A-1, Apo B), tolerability and safety in pediatric subjects with HeFH receiving atorvastatin treatment. [ Time Frame: 4 July 2013 ] [ Designated as safety issue: No ]
Change HistoryComplete list of historical versions of study NCT00827606 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 29, 2009)		To estimate long-term, three year efficacy via the descriptive exploratory biomarker of Flow Mediated Dilation (FMD) in a subset of the HeFH pediatric subjects treated with atorvastatin in this study [ Time Frame: 3 monthly visits post treatment initiation, next visit 3 months later, then every 6 months for the r ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: January 22, 2009)		To estimate long-term, three year efficacy via the descriptive exploratory biomarker of Flow Mediated Dilation (FMD) in a subset of the HeFH pediatric subjects treated with atorvastatin in this study [ Time Frame: 4 July 2013 ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title  ICMJEAtorvastatin Three Year Pediatric Study
Official Title  ICMJEA 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 
Study PhasePhase II, Phase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJEFamilial Hypercholesterolemia
Intervention  ICMJEDrug: atorvastatin
Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years
Study Arms / Comparison GroupsAtorvastatin: Experimental
All subjects will be treated with atorvastatin
Intervention: Drug: atorvastatin

Recruitment Information

Estimated Enrollment  ICMJE250
Estimated Completion DateJuly 2013
Estimated Primary Completion DateJuly 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

GenderBoth
Ages6 Years to 15 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Belgium,   Canada,   Greece,   Hungary,   Italy,   Norway,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   Spain,   Turkey

Administrative Information

NCT ID  ICMJENCT00827606
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA2581173
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer