At a glance
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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
In Brief
A Phase 3 clinical trial evaluating rosuvastatin calcium for Familial Hypercholesterolaemia. Completed, enrolled 315 participants across 15 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
5 mg, oral, once daily, 24 months
10 mg, oral, once daily, 24 months
20 mg, oral, once daily, 24 months