Atorvastatin Three Year Pediatric Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00827606
First received: January 21, 2009
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

The purpose of this study is 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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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: 3 monthly visits post treatment initiation, next visit 3 months later, then every 6 months for the r ] [ 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: 3 monthly visits post treatment initiation, next visit 3 months later, then every 6 months for the r ] [ 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: 3 monthly visits post treatment initiation, next visit 3 months later, then every 6 months for the r ] [ Designated as safety issue: No ]

Enrollment: 272
Study Start Date: March 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin
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 (an 80 mg maximum daily dose is delivered by taking two 40 mg strengths, once daily)

  Eligibility

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

Inclusion Criteria:

  • Heterozygous 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85016
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
Pfizer Investigational Site
Gainesville, Florida, United States, 32610
Pfizer Investigational Site
Gainesville, Florida, United States, 32608
United States, Maryland
Pfizer Investigational Site
Balitmore, Maryland, United States, 21287
Pfizer Investigational Site
Baltimore, Maryland, United States, 21205
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45212
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1200
Pfizer Investigational Site
Leuven, Belgium, 3000
Canada, Quebec
Pfizer Investigational Site
Sainte-Foy,, Quebec, Canada, G1V 4M6
Germany
Pfizer Investigational Site
Berlin, Germany, 13353
Pfizer Investigational Site
Freiburg, Germany, 79106
Pfizer Investigational Site
Freiburg, Germany, 79098
Greece
Pfizer Investigational Site
Athens, Greece, 115 27
Pfizer Investigational Site
Athens, Greece, 112 51
Hungary
Pfizer Investigational Site
Budapest, Hungary, H1094
Pfizer Investigational Site
Szekesfehervar, Hungary, 8000
Italy
Pfizer Investigational Site
Palermo, Italy, 90127
Pfizer Investigational Site
Rome, Italy, 00161
Norway
Pfizer Investigational Site
Oslo, Norway, 0027
Poland
Pfizer Investigational Site
Bydgoszcz, Poland, 85-667
Pfizer Investigational Site
Warszawa, Poland, 04-730
Puerto Rico
Pfizer Investigational Site
San German, Puerto Rico, 00683
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 117997
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 194291
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 196084
Pfizer Investigational Site
St Petersburg, Russian Federation, 194044
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 833 40
Pfizer Investigational Site
Kosice, Slovakia, 040 01
Pfizer Investigational Site
Kosice, Slovakia, 040 11
Pfizer Investigational Site
Poprad, Slovakia, 05801
Pfizer Investigational Site
Trencin, Slovakia, 911 71
Spain
Pfizer Investigational Site
Elche, Alicante, Spain, 03202
Pfizer Investigational Site
Merida, Badajoz, Spain, 06800
Pfizer Investigational Site
Santander, Cantabria, Spain, 39008
Pfizer Investigational Site
Barcelona, Spain, 08950
Pfizer Investigational Site
Barcelona, Spain, 08041
Switzerland
Pfizer Investigational Site
CH-3010 Bern, Switzerland
Turkey
Pfizer Investigational Site
Ankara, Turkey, 06100
Pfizer Investigational Site
Ankara, Turkey, 06500
Pfizer Investigational Site
Izmir, Turkey, 35100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00827606     History of Changes
Other Study ID Numbers: A2581173
Study First Received: January 21, 2009
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pediatric heterozygous familial hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014