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Trial record 1 of 1 for:    NCT00827606
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Atorvastatin Three Year Pediatric Study

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ClinicalTrials.gov Identifier: NCT00827606
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : June 2, 2015
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE January 21, 2009
First Posted Date  ICMJE January 23, 2009
Results First Submitted Date  ICMJE September 11, 2014
Results First Posted Date  ICMJE June 2, 2015
Last Update Posted Date February 21, 2021
Study Start Date  ICMJE March 2009
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
  • Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET]) ]
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
  • Percent Change From Baseline in LDL-C [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET) ]
    Assessments were performed in the fasting state (minimum 10-hour fast).
  • High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
  • Percent Change From Baseline in HDL-C [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast).
  • Total Cholesterol (mMol/L) During the Study [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
  • Percent Change From Baseline in Total Cholesterol [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast).
  • Trigylcerides (mMol/L) During the Study [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
  • Percent Change From Baseline in Trigylcerides [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast).
  • Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
  • Percent Change From Baseline in VLDL [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast).
  • Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
  • Percent Change From Baseline in Apo A-1 [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast).
  • Apoliprotein B (Apo B; g/L) During the Study [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
  • Percent Change From Baseline in Apo B [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Assessments were performed in the fasting state (minimum 10-hour fast).
  • Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage [ Time Frame: Baseline, Months 6, 12, 18, 24, 30, and 36/ET ]
    Tanner_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner_Stage had the higher value of 2 components for each gender by visit.
  • Height (Centimeters [cm]) During the Study: Males [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of height changes during the study. Change from baseline was also determined.
  • Percent Change From Baseline in Height: Males [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of height changes during the study.
  • Height (cm) During the Study: Females [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of height changes during the study. Change from baseline was also determined.
  • Percent Change From Baseline in Height: Females [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of height changes during the study.
  • Weight (Kilograms [kg]) During the Study: Males [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of weight changes during the study. Change from baseline was also determined.
  • Percent Change From Baseline in Weight: Males [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of weight changes during the study.
  • Weight (kg) During the Study: Females [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of weight changes during the study. Change from baseline was also determined.
  • Percent Change From Baseline in Weight: Females [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of weight changes during the study.
  • Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of BMI changes during the study. Change from baseline was also determined.
  • Percent Change From Baseline in BMI: Males [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of BMI changes during the study.
  • BMI (kg/m^2) During the Study: Females [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of BMI changes during the study. Change from baseline was also determined.
  • Percent Change From Baseline in BMI: Females [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of BMI changes during the study.
  • Age (Years) During the Study: Males [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of age during the study. Change from baseline was also determined.
  • Percent Change From Baseline in Age: Males [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of age during the study.
  • Age (Years) During the Study: Females [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of age during the study. Change from baseline was also determined.
  • Percent Change From Baseline in Age: Females [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET ]
    Investigator assessment of age during the study.
  • Flow-Mediated Dilatation (FMD) During the Study [ Time Frame: Baseline, Months 6, 12, 18, 24, 30 and 36/ET ]
    Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.
  • Percent Change From Baseline in FMD [ Time Frame: Months 6, 12, 18, 24, 30 and 36/ET ]
    Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.
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 ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
  • Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination) ]
  • Percentage of Participants by Study Drug Compliance Category [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination) ]
    Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

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