You are here

Our science / Clinical Trials / Find a Trial / NCT00739999

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

Back to Search Print Save as PDF Bookmark Trial

NCT00739999

Last updated on December 17, 2017
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Quebec, , G1V 4G2 Canada
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Hypercholesterolemia Coronary Artery Disease
Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting
NCT02565615
All Genders
18+
Years
Multiple Sites
Pediatric Psoriasis
Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
NCT01432249
All Genders
Pediatric Safety and Effectiveness
Vfend Special Investigation For Pediatric - Observational
NCT02554656
All Genders
0+
Years
Osaka,
Hypertension, Angina Pectoris, Hypercholesterolemia, Familial Hypercholesterolemia
Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT01107743
All Genders
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

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now