An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia

Familial Hypercholesterolaemia Clinical Trial

Official title: An Efficacy and 2-Year Safety Study of Open-label Rosuvastatin in Children and Adolescents (Aged From 6 to Less Than 18 Years) With Familial Hypercholesterolaemia

Status Completed

Clinical Trial Summary

This study is being carried out to see if the study medication, rosuvastatin, is effective in treating familial hypercholesterolaemia in children and adolescents, and to determine the long term (over 2 years) safety, tolerability and efficacy of the study medication in these patients.

This study will also measure levels of drug in the blood and see how well it is tolerated. This is known as pharmacokinetic (PK) analysis.

At baseline only a small number of patients will participate in a single dose PK phase over 24 hours.

In order to see if this medication works, a control group of healthy siblings will help the researchers to compare certain results.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Familial Hypercholesterolaemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

• NCT number: NCT01078675
• Study type: Interventional
• Source: AstraZeneca
• Status: Completed
• Phase: Phase 3
• Start date: February 2010
• Completion date: February 2013