Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
Phase 3
Completed
- Conditions
- Heterozygous Familial HypercholesterolemiaMixed Dyslipidemia
- Registration Number
- NCT00171236
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
- 10-16 years old Heterozygous familial hypercholesterolemia
Exclusion Criteria
- Homozygous familial hypercholesterolemia Pregnant or lactating females Major surgery during the six month prior study
Other protocol defined inclusion and exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which fluvastatin lowers LDL-C in children with heterozygous familial hypercholesterolemia (HeFH)?
How does fluvastatin compare to ezetimibe or PCSK9 inhibitors in treating HeFH in pediatric populations?
Which biomarkers correlate with fluvastatin treatment response in NCT00171236 pediatric HeFH trial?
What are the long-term safety profiles of statins like fluvastatin in children with HeFH and mixed dyslipidemia?
How do fluvastatin's HMG-CoA reductase inhibition effects interact with other lipid-lowering therapies in pediatric HeFH management?
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland
Novartis🇨🇭Basel, Switzerland