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Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00171236
Collaborator
(none)
84
Enrollment
1
Location
41
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
Study Start Date :
Oct 1, 2001
Actual Primary Completion Date :
Mar 1, 2005
Actual Study Completion Date :
Mar 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Basel Switzerland

    Sponsors and Collaborators

    • Novartis

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis
    ClinicalTrials.gov Identifier:
    NCT00171236
    Other Study ID Numbers:
    • CXUO320B2301
    First Posted:
    Sep 15, 2005
    Last Update Posted:
    Nov 8, 2011
    Last Verified:
    Sep 1, 2005
    Keywords provided by Novartis
    Heterozygous familial hypercholesterolemia
    mixed dyslipidemia
    Additional relevant MeSH terms:
    Hyperlipoproteinemia Type II
    Hypercholesterolemia
    Dyslipidemias

    Study Results

    No Results Posted as of Nov 8, 2011