An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia
Completed · Phase 3
Conditions studied: Familial Hypercholesterolaemia
In brief
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.
Key facts
- Study ID
- NCT01078675
- Run by
- AstraZeneca
- People needed
- 315
- Starts
- 2010-02-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2015-04-07
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- History of muscle or sensitivity reactions to any statin medicines
- Current active liver disease or dysfunction (except a confirmed diagnosis of Gilbert's disease)
Where it is running
- Research Site — Cincinnati, Ohio, United States
- Research Site — Leuven, Belgium, Belgium
- Research Site — Leuven, Belgium
- Research Site — Vancouver, British Columbia, Canada
- Research Site — Hamilton, Ontario, Canada
- Research Site — Toronto, Ontario, Canada
- Research Site — Chicoutimi, Quebec, Canada
- Research Site — Québec, Quebec, Canada
- Research Site — Amsterdam, Netherlands
- Research Site — Groningen, Netherlands
- Research Site — Hoorn, Netherlands
- Research Site — Leiderdorp, Netherlands
- Research Site — Rotterdam, Netherlands
- Research Site — Waalwijk, Netherlands
- Research Site — Oslo, Norway
Full record on ClinicalTrials.gov
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