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

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NCT00739999

Last updated on August 9, 2018
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Study Location
Pfizer Investigational Site
Quebec, , G1V 4G2 Canada
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pediatric Heterozygous Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Genetically confirmed heterozygous familial hypercholesterolemia (HeFH) with LDL
greater or equal 4 mmol/L at baseline

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant diseases, homozygous familial
hypercholesterolemia (FH)

NCT00739999
Pfizer
Completed
8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia

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8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
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
To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia
Not Provided
Interventional
Phase 1
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Pediatric Heterozygous Hypercholesterolemia
  • Drug: Atorvastatin
    6-10 years Tanner Stage 1 will be administered 5-mg daily dose of an atorvastatin pediatric tablet formulation. Dose may be doubled if subjects have not attained target LDL (<3.35 mmol/L) after 4-week treatment.
  • Drug: Atorvastatin
    10-17 years Tanner Stage 2 will be administered 10-mg daily dose of atorvastatin tablet formulation. Dose may be doubled if subjects have not attained target LDL (<3.35 mmol/L) after 4-week treatment.
  • 1
    6-10 years will be administered with atorvastatin tablet formulation with initial doses based on age cohort.
    Intervention: Drug: Atorvastatin
  • 2
    10-17 years will be administered 10-mg daily dose of atorvastatin tablet formulation.
    Intervention: Drug: Atorvastatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
May 2009
May 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Greece,   Norway
 
 
NCT00739999
A2581172
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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