Phase 1 N=39 Other

8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia

Pediatric Heterozygous Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT00739999 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2010

Primary outcome: Primary: Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F) — 553; 543 L/hr

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Atorvastatin (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F)	553; 543	—
PRIMARY Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F)	1020	—
SECONDARY Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)	4.87; 6.37; 5.11; 6.23; -1.75; -1.62	—
SECONDARY Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)	-36.27; -25.70; -38.14; -30.27; -42.33; -30.27	—
SECONDARY Absolute Change From Baseline in Total Cholesterol (TC)	6.76; 8.58; 6.92; 8.40; -1.89; -2.04	—
SECONDARY Percent Change From Baseline in Total Cholesterol (TC)	-28.06; -24.11; -30.60; -26.78; -33.37; -26.12	—
SECONDARY Absolute Change From Baseline in Triglycerides (TG)	0.76; 0.95; 1.03; 1.20; 0.05; -0.08	—
SECONDARY Percent Change From Baseline in Triglycerides (TG)	5.66; -6.87; 28.37; -0.56; -6.20; -21.43	—
SECONDARY Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)	1.35; 1.45; 1.17; 1.18; 0.08; -0.10	—
SECONDARY Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)	5.38; -6.45; -4.11; -0.77; -1.99; 1.59	—
SECONDARY Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1)	1.42; 1.45; 1.29; 1.24; 0.01; -0.08	—
SECONDARY Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1)	1.69; -5.24; -5.96; -0.53; -5.15; -3.30	—
SECONDARY Absolute Change From Baseline in Apolipoprotein B (Apo B)	1.09; 1.49; 1.26; 1.52; -0.23; -0.31	—
SECONDARY Percent Change From Baseline in Apolipoprotein B (Apo B)	-21.92; -19.88; -30.81; -27.46; -29.89; -26.56	—
SECONDARY Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)	0.54; 0.76; 0.65; 0.99; -0.22; -0.31	—
SECONDARY Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)	-42.20; -28.49; -14.50; -39.95; -30.66; -31.86	—
SECONDARY Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8	4.34; 7.41; 5.05; 3.67; -0.16; -1.14	—
SECONDARY Percent Change From Baseline in Flow-Mediated Dilatation at Week 8	-17.19; -20.77; -9.77; 1.49	—

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00739999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.