Atorvastatin Three Year Pediatric Study
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| ClinicalTrials.gov Identifier: NCT00827606 |
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Recruitment Status :
Completed
First Posted : January 23, 2009
Results First Posted : June 2, 2015
Last Update Posted : February 21, 2021
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Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Familial Hypercholesterolemia | Drug: atorvastatin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 272 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official 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 |
| Study Start Date : | March 2009 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | October 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial hypercholesterolemia
| Arm | Intervention/treatment |
|---|---|
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Experimental: Atorvastatin
All subjects will be treated with atorvastatin
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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) |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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%.
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| Ages Eligible for Study: | 6 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827606
Locations
Show 40 study locations
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| ClinicalTrials.gov Identifier: | NCT00827606 |
| Other Study ID Numbers: |
A2581173 2008-006130-95 ( EudraCT Number ) |
| First Posted: | January 23, 2009 Key Record Dates |
| Results First Posted: | June 2, 2015 |
| Last Update Posted: | February 21, 2021 |
| Last Verified: | February 2021 |
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
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pediatric heterozygous familial hypercholesterolemia |
Additional relevant MeSH terms:
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Atorvastatin Hyperlipoproteinemia Type II Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors |
Genetic Diseases, Inborn Hyperlipoproteinemias Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |