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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Calcium; Calcium, Dietary; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• children and adolescents (aged 6 to less than 18 years) with Familial Hypercholesterolaemia

• Patients aged between 6 and less than 10 years of age must not be taking a statin medicine

Exclusion Criteria:

• History of muscle or sensitivity reactions to any statin medicines

• Current active liver disease or dysfunction (except a confirmed diagnosis of Gilbert's disease)