NCT01078675

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Familial Hypercholesterolaemia

Interventions

Type	Name	Description
DRUG	rosuvastatin calcium	5 mg, oral, once daily, 24 months
DRUG	rosuvastatin calcium	10 mg, oral, once daily, 24 months
DRUG	rosuvastatin calcium	20 mg, oral, once daily, 24 months

Timeline

• Start date: 2010-02-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-03-02
• Last updated: 2015-04-07
• Results posted: 2015-02-02

Locations

15 sites across 5 countries: United States, Belgium, Canada, Netherlands, Norway