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Atorvastatin pediatric appropriate formulation

Phase 4

Hypercholesterolemia | Small molecule | Metabolic |Pfizer, Inc.|Trials Updated: Feb 18, 2021

Atorvastatin pediatric appropriate formulation development status

Highest phase Phase 4 (NCT00647543)
Phase scored for PFEPhase 1
Registered trials 173 across 40 sponsors since Oct 2004

Atorvastatin pediatric appropriate formulation target and mechanism

Molecular targetHMGCR
Target classInhibitor
ModalitySmall molecule

Also known as Atorvastatin

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Atorvastatin pediatric appropriate formulation clinical trials

Atorvastatin pediatric appropriate formulation · 1 trial · 1 indication

Phase 1 1
NCT00758004Bioequivalence Study Of Pediatric Appropriate FormulationHypercholesterolemia
COMPLETED76 Analytics
PHASE1COMPLETED
Bioequivalence Study Of Pediatric Appropriate Formulation
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data.
5 months

Secondary Endpoints

Secondary endpoints will include Tmax and t1/2 (if data permit) of atorvastatin ; AUClast, AUCinf, Cmax, Tmax, and t1/2 (if data permit) of o-hydroxyatorvastatin and p-hydroxyatorvastatin.
5 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
ReferenceOTHERCommercial 80 mg atorvastatin tablet
TestOTHERPediatric appropriate atorvastatin 40mg formulation

Interventions

NameTypeDescription
AtorvastatinDRUGA single dose of 80 mg atrovastatin tablet
Atorvastatin pediatric appropriate formulationDRUGA single dose of pediatric appropriate atorvastatin 80 mg formulation
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female volunteers * Mass Index (BMI) of approximately 18 to 30 kg/m2 Exclusion Criteria: * Any condition possibly affecting drug absorption * A positive urine drug screening

Countries:United States
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Frequently asked questions about Atorvastatin pediatric appropriate formulation

What is Atorvastatin pediatric appropriate formulation?

Atorvastatin pediatric appropriate formulation is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) for hypercholesterolemia. It is a pediatric-oriented version of atorvastatin studied in a Phase 1 bioequivalence trial. The program is in clinical development and is not described as approved.

What does Atorvastatin pediatric appropriate formulation target?

Atorvastatin pediatric appropriate formulation targets HMGCR, also known as HMG-CoA reductase. It acts as an inhibitor of this enzyme, the same molecular target class as other statin therapies used to lower cholesterol. The drug is a small molecule being studied in hypercholesterolemia.

Who makes Atorvastatin pediatric appropriate formulation?

Pfizer, Inc. is the developer of Atorvastatin pediatric appropriate formulation. Pfizer trades under the ticker PFE. The company is running the clinical program for this pediatric-oriented atorvastatin formulation in hypercholesterolemia.

What phase is Atorvastatin pediatric appropriate formulation in?

Atorvastatin pediatric appropriate formulation is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The program remains investigational and is not described as FDA approved.

What clinical trials is Atorvastatin pediatric appropriate formulation in?

Atorvastatin pediatric appropriate formulation has been studied in one completed Phase 1 trial, NCT00758004, titled Bioequivalence Study Of Pediatric Appropriate Formulation. That randomized, controlled trial enrolled 76 healthy adult volunteers in the United States and evaluated hypercholesterolemia-related bioequivalence. No active trials are ongoing.