Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Phase 3

Completed

• Conditions: Heterozygous Familial Hypercholesterolemia; Mixed Dyslipidemia

• Registration Number: NCT00171236
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland