Conditions: Familial Hypercholesterolaemia
Keywords: Familial Hypercholesterolaemia pediatric
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 315
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: rosuvastatin calcium intervention 2: rosuvastatin calcium intervention 3: rosuvastatin calcium
Intervention descriptions: intervention 1: 5 mg, oral, once daily, 24 months intervention 2: 10 mg, oral, once daily, 24 months intervention 3: 20 mg, oral, once daily, 24 months

Protocol document: