Atorvastatin Three Year Pediatric Study

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.272 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

272

Conditions

Familial Hypercholesterolemia

Interventions

atorvastatinDRUG

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)

Eligibility

Sex: ALLMin age: 6 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (40)

Outcomes

Primary Outcomes

Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study

Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])

Percent Change From Baseline in LDL-C

Assessments were performed in the fasting state (minimum 10-hour fast).

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)

High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study

Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in HDL-C

Assessments were performed in the fasting state (minimum 10-hour fast).

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Total Cholesterol (mMol/L) During the Study

Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in Total Cholesterol

Assessments were performed in the fasting state (minimum 10-hour fast).

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Trigylcerides (mMol/L) During the Study

Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Data from ClinicalTrials.gov

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Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's National Medical Center

Washington D.C., 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

Brussels, Belgium

Universitaire Ziekenhuizen Leuven / Center for Metabolic Diseases

Leuven, Belgium

Clinique des Maladies Lipidiques de Quebec

Québec, Quebec, Canada

...and 30 more locations

Percent Change From Baseline in Trigylcerides

Assessments were performed in the fasting state (minimum 10-hour fast).

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study

Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in VLDL

Assessments were performed in the fasting state (minimum 10-hour fast).

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study

Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in Apo A-1

Assessments were performed in the fasting state (minimum 10-hour fast).

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Apoliprotein B (Apo B; g/L) During the Study

Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in Apo B

Assessments were performed in the fasting state (minimum 10-hour fast).

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage

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.

Time frame: Baseline, Months 6, 12, 18, 24, 30, and 36/ET

Height (Centimeters [cm]) During the Study: Males

Investigator assessment of height changes during the study. Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in Height: Males

Investigator assessment of height changes during the study.

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Height (cm) During the Study: Females

Investigator assessment of height changes during the study. Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in Height: Females

Investigator assessment of height changes during the study.

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Weight (Kilograms [kg]) During the Study: Males

Investigator assessment of weight changes during the study. Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in Weight: Males

Investigator assessment of weight changes during the study.

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Weight (kg) During the Study: Females

Investigator assessment of weight changes during the study. Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in Weight: Females

Investigator assessment of weight changes during the study.

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males

Investigator assessment of BMI changes during the study. Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in BMI: Males

Investigator assessment of BMI changes during the study.

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

BMI (kg/m^2) During the Study: Females

Investigator assessment of BMI changes during the study. Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in BMI: Females

Investigator assessment of BMI changes during the study.

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Age (Years) During the Study: Males

Investigator assessment of age during the study. Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in Age: Males

Investigator assessment of age during the study.

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Age (Years) During the Study: Females

Investigator assessment of age during the study. Change from baseline was also determined.

Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in Age: Females

Investigator assessment of age during the study.

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Flow-Mediated Dilatation (FMD) During the Study

Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.

Time frame: Baseline, Months 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in FMD

Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.

Time frame: Months 6, 12, 18, 24, 30 and 36/ET

Secondary Outcomes

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

Compliance to study drug was categorized as \<80%, 80% - 120%, and greater than (\>) 120%.

Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)