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

Viatris

Status and phase: Completed; Phase 1

Conditions: Pediatric Heterozygous Hypercholesterolemia

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739999

A2581172

Details and patient eligibility

About

To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia

Enrollment: 39 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

1

Other group

Description:

6-10 years will be administered with atorvastatin tablet formulation with initial doses based on age cohort.

Treatment:

Drug: Atorvastatin

Drug: Atorvastatin

2

Other group

Description:

10-17 years will be administered 10-mg daily dose of atorvastatin tablet formulation.

Treatment:

Drug: Atorvastatin

Drug: Atorvastatin