8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatric Heterozygous Hypercholesterolemia
Intervention: Atorvastatin (Drug); Atorvastatin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in
children and adolescents with heterozygous familial hypercholesterolemia
Clinical Details
Official title: A 8-Week, Open-Label, Phase 1 Study To Evaluate Pharmacokinetics, Pharmacodynamics, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F)Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F)
Secondary outcome: Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) Absolute Change From Baseline in Total Cholesterol (TC) Percent Change From Baseline in Total Cholesterol (TC) Absolute Change From Baseline in Triglycerides (TG) Percent Change From Baseline in Triglycerides (TG) Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) Absolute Change From Baseline in Apolipoprotein B (Apo B) Percent Change From Baseline in Apolipoprotein B (Apo B) Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8 Percent Change From Baseline in Flow-Mediated Dilatation at Week 8
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Genetically confirmed heterozygous familial hypercholesterolemia (HeFH) with LDL
greater or equal 4 mmol/L at baseline
Exclusion Criteria:
- Evidence or history of clinically significant diseases, homozygous familial
hypercholesterolemia (FH)
Locations and Contacts
Pfizer Investigational Site, Quebec G1V 4G2, Canada
Pfizer Investigational Site, Athens 115 27, Greece
Pfizer Investigational Site, Oslo 0027, Norway
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: December 2008
Last updated: August 19, 2010
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