Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

This study has been completed.

First Received: September 12, 2005 No Changes Posted

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171236

Purpose

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

Condition	Intervention	Phase
Heterozygous Familial Hypercholesterolemia Mixed Dyslipidemia	Drug: Fluvastatin	Phase III

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics: Cholesterol

Drug Information available for: Fluvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Further study details as provided by Novartis:

Study Start Date:

October 2001

Eligibility

Ages Eligible for Study:	10 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171236

Locations

Switzerland
Novartis
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CXUO320B2301
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00171236 History of Changes
Health Authority:	Netherlands: Medicines Evaluation Board (MEB); United States: Food and Drug Administration

Keywords provided by Novartis:

Heterozygous familial hypercholesterolemia
mixed dyslipidemia

Study placed in the following topic categories:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Antilipemic Agents
Hyperlipoproteinemia Type II
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Fluvastatin

Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hypercholesterolemia, Autosomal Dominant
Hypercholesterolemia
Metabolic Disorder
Dyslipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Hyperlipoproteinemia Type II
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Fluvastatin
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009