Clinical trial NCT00739999: 8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pediatric Heterozygous Hypercholesterolemia
Keywords: heterozygous familial hypercholesterolemia (HeFH); atorvastatin; pediatric
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia


Eligibility 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)

Primary outcomes:
measure: Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F)
timeFrame: Week 2, Week 4, Week 6, Week 8
measure: Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F)
timeFrame: Week 2, Week 4, Week 6, Week 8
Secondary outcomes:
measure: Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Absolute Change From Baseline in Total Cholesterol (TC)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Percent Change From Baseline in Total Cholesterol (TC)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Absolute Change From Baseline in Triglycerides (TG)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Percent Change From Baseline in Triglycerides (TG)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Absolute Change From Baseline in Apolipoprotein B (Apo B)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Percent Change From Baseline in Apolipoprotein B (Apo B)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8
measure: Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8
timeFrame: Baseline, Week 8
measure: Percent Change From Baseline in Flow-Mediated Dilatation at Week 8
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: