An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
315 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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