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...

Date First Received: September 12, 2005

Last Updated: September 12, 2005

Verified by: Novartis, September 2005

Clinical Trial Phase: Phase 3 | Start Date: October 2001

Overall Status: Completed

Brief Summary

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

Intervention(s):

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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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 Sponsor Information

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

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)

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.