Conditions: Pediatric Heterozygous Hypercholesterolemia
Keywords: heterozygous familial hypercholesterolemia (HeFH); atorvastatin; pediatric
Allocation: NA | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: 6-10 years will be administered with atorvastatin tablet formulation with initial doses based on age cohort. arm 2: 10-17 years will be administered 10-mg daily dose of atorvastatin tablet formulation.

Interventions: intervention 1: Atorvastatin intervention 2: Atorvastatin
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: