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Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171236
First Posted: September 15, 2005
Last Update Posted: November 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
September 12, 2005
September 15, 2005
November 8, 2011
October 2001
March 2005   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00171236 on ClinicalTrials.gov Archive Site
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Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
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
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Heterozygous Familial Hypercholesterolemia
  • Mixed Dyslipidemia
Drug: Fluvastatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
March 2005
March 2005   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
10 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00171236
CXUO320B2301
Not Provided
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Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP