Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

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The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial...

Brief Summary

Official Title: “Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia”

The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: March 2005

Intervention(s) in this Clinical Trial

  • Drug: Fluvastatin

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171236

Study ID Number: CXUO320B2301

ClinicalTrials.gov Identifier: NCT00171236

Health Authority: Netherlands: Medicines Evaluation Board (MEB)

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00171236