Atorvastatin Three Year Pediatric Study - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00827606

Purpose

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	Intervention	Phase
Familial Hypercholesterolemia	Drug: atorvastatin	Phase II Phase III

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

• To characterize long-term, three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) in pediatric subjects with HeFH receiving atorvastatin treatment [ Time Frame: 4 July 2013 ] [ Designated as safety issue: No ]
• To characterize long-term, three year descriptive efficacy (LDL-C, TC, TG, HDL, VLDL, Apo A-1, Apo B), tolerability and safety in pediatric subjects with HeFH receiving atorvastatin treatment. [ Time Frame: 4 July 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• To estimate long-term, three year efficacy via the descriptive exploratory biomarker of Flow Mediated Dilation (FMD) in a subset of the HeFH pediatric subjects treated with atorvastatin in this study [ Time Frame: 4 July 2013 ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	March 2009
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Atorvastatin: Experimental All subjects will be treated with atorvastatin	Drug: atorvastatin Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years

Eligibility

Ages Eligible for Study:	6 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hetrozygous 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827606

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, Arkansas
Pfizer Investigational Site	Recruiting
Little Rock, Arkansas, United States, 72205
Canada, Quebec
Pfizer Investigational Site	Not yet recruiting
Québec, Quebec, Canada, G1V 4M6
Puerto Rico
Pfizer Investigational Site	Recruiting
San German, Puerto Rico, 00683

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2581173
Study First Received:	January 21, 2009
Last Updated:	May 3, 2009
ClinicalTrials.gov Identifier:	NCT00827606 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by Pfizer:

pediatric heterozygous familial hypercholesterolemia

Study placed in the following topic categories:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Antilipemic Agents
Hyperlipoproteinemia Type II
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolism, Inborn Errors

Genetic Diseases, Inborn
Hypercholesterolemia, Autosomal Dominant
Hypercholesterolemia
Metabolic Disorder
Hyperlipoproteinemias
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Hyperlipoproteinemia Type II
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Hyperlipoproteinemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009