Status:
COMPLETED
8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Pediatric Heterozygous Hypercholesterolemia
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
Brief Summary
To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia
Eligibility Criteria
Inclusion
- Genetically confirmed heterozygous familial hypercholesterolemia (HeFH) with LDL greater or equal 4 mmol/L at baseline
Exclusion
- Evidence or history of clinically significant diseases, homozygous familial hypercholesterolemia (FH)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00739999
Start Date
December 1 2008
End Date
May 1 2009
Last Update
March 15 2021
Active Locations (3)
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1
Pfizer Investigational Site
Québec, Quebec, Canada, G1V 4G2
2
Pfizer Investigational Site
Athens, Greece, 115 27
3
Pfizer Investigational Site
Oslo, Norway, 0027