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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

Page last updated: August 23, 2015

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