Back to resultsEfficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
Primary Purpose
Heterozygous Familial Hypercholesterolemia, Mixed Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Fluvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Heterozygous Familial Hypercholesterolemia focused on measuring Heterozygous familial hypercholesterolemia, mixed dyslipidemia
Eligibility Criteria
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
Sites / Locations
- Novartis
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171236
Brief Title
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
Official Title
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heterozygous Familial Hypercholesterolemia, Mixed Dyslipidemia
Keywords
Heterozygous familial hypercholesterolemia, mixed dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluvastatin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
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