Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Novartis

Status and phase: Completed; Phase 3

Conditions: Mixed Dyslipidemia; Heterozygous Familial Hypercholesterolemia

Treatments: Drug: Fluvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171236

CXUO320B2301

Details and patient eligibility

About

The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia

Enrollment: 84 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 10-16 years old Heterozygous familial hypercholesterolemia

Exclusion criteria

• Homozygous familial hypercholesterolemia Pregnant or lactating females Major surgery during the six month prior study

Other protocol defined inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)