Atorvastatin Three Year Pediatric Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00827606
First received: January 21, 2009
Last updated: November 4, 2013
Last verified: November 2013

January 21, 2009
November 4, 2013
March 2009
October 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00827606 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
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 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Both
6 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Germany,   Greece,   Hungary,   Italy,   Norway,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   Spain,   Switzerland,   Turkey
 
NCT00827606
A2581173
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

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