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: June 1, 2015
Last verified: June 2015

January 21, 2009
June 1, 2015
March 2009
October 2013   (final data collection date for primary outcome measure)
  • 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]) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.
  • 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
  • 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) ] [ Designated as safety issue: No ]
  • Percentage of Participants by Study Drug Compliance Category [ Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination) ] [ Designated as safety issue: No ]
    Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.
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 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
Puerto Rico
 
NCT00827606
A2581173, 2008-006130-95
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

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