Atorvastatin Three Year Pediatric Study
- Registration Number
- NCT00827606
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
- Heterozygous familial hypercholesterolemia, ages 6-15, LDL greater than 4 mmol/l
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atorvastatin atorvastatin All subjects will be treated with atorvastatin
- Primary Outcome Measures
Name Time Method Apoliprotein B (Apo B; g/L) During the Study 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.
Age (Years) During the Study: Females 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.
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study 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.
Total Cholesterol (mMol/L) During the Study 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 Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET Assessments were performed in the fasting state (minimum 10-hour fast).
Percent Change From Baseline in VLDL Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET Assessments were performed in the fasting state (minimum 10-hour fast).
Percent Change From Baseline in Height: Males 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 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.
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males 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 Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET Investigator assessment of BMI changes during the study.
Percent Change From Baseline in BMI: Females Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET Investigator assessment of BMI changes during the study.
Percent Change From Baseline in Age: Females 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 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.
Trigylcerides (mMol/L) During the Study 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 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 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.
Weight (kg) During the Study: Females 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 Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET Investigator assessment of weight changes during the study.
BMI (kg/m^2) During the Study: Females 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.
Age (Years) During the Study: Males 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 HDL-C 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 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.
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study 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 Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET Assessments were performed in the fasting state (minimum 10-hour fast).
Height (Centimeters [cm]) During the Study: Males 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 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 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 Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET Investigator assessment of weight changes during the study.
Percent Change From Baseline in Age: Males Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET Investigator assessment of age during the study.
Percent Change From Baseline in FMD 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.
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study 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 Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET) Assessments were performed in the fasting state (minimum 10-hour fast).
Percent Change From Baseline in Total Cholesterol Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET Assessments were performed in the fasting state (minimum 10-hour fast).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination) Percentage of Participants by Study Drug Compliance Category 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%.
Trial Locations
- Locations (40)
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
MEDPACE Clinical Pharmacology Unit
🇺🇸Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Cliniques Universitaires Saint-Luc / Pediatrie generale
🇧🇪Bruxelles, Belgium
Universitaire Ziekenhuizen Leuven / Center for Metabolic Diseases
🇧🇪Leuven, Belgium
Clinique des maladies lipidiques de Quebec Inc
🇨🇦Sainte-Foy,, Quebec, Canada
Scroll for more (30 remaining)Phoenix Children's Hospital🇺🇸Phoenix, Arizona, United States