Atorvastatin Three Year Pediatric Study

• Register: ClinicalTrials.gov
• Last refreshed on: 1 March 2021
• Main ID: NCT00827606
• Date of registration: 21/01/2009
• Prospective Registration: Yes
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: Atorvastatin Three Year Pediatric Study
• Scientific title: A Three Year, Prospective, Open-label, Study To Evaluate Clinical Efficacy, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
• Date of first enrolment: March 2009
• Target sample size: 272
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00827606
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Germany, Greece, Hungary, Italy, Norway, Poland, Puerto Rico, Russian Federation, Slovakia, Spain, Switzerland, Turkey, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 6 Years
Age maximum: 15 Years
Gender: All

Health Condition(s) or Problem(s) studied

Familial Hypercholesterolemia

Intervention(s)

Drug: atorvastatin

Primary Outcome(s)

Apoliprotein B (Apo B; g/L) During the Study [Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

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])]

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]

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]

Height (cm) During the Study: Females [Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in Age: Males [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

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]

Percent Change From Baseline in BMI: Females [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in BMI: Males [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in Height: Males [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in FMD [Time Frame: Months 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in Total Cholesterol [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Age (Years) During the Study: Females [Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Height (Centimeters [cm]) During the Study: Males [Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in LDL-C [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)]

Percent Change From Baseline in HDL-C [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Age (Years) During the Study: Males [Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in Apo B [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Total Cholesterol (mMol/L) During the Study [Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Flow-Mediated Dilatation (FMD) During the Study [Time Frame: Baseline, Months 6, 12, 18, 24, 30 and 36/ET]

Trigylcerides (mMol/L) During the Study [Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in Apo A-1 [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in Height: Females [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in Weight: Females [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in Trigylcerides [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Weight (Kilograms [kg]) During the Study: Males [Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in VLDL [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in Weight: Males [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Weight (kg) During the Study: Females [Time Frame: Baseline, 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 [Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

BMI (kg/m^2) During the Study: Females [Time Frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

Percent Change From Baseline in Age: Females [Time Frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET]

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]

Secondary Outcome(s)

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)]

Secondary ID(s)

2008-006130-95

A2581173

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/06/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00827606