Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171236
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: September 2005
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Novartis:

Enrollment: 84
Study Start Date: October 2001
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171236     History of Changes
Other Study ID Numbers: CXUO320B2301
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: Netherlands: Medicines Evaluation Board (MEB)
United States: Food and Drug Administration

Keywords provided by Novartis:
Heterozygous familial hypercholesterolemia
mixed dyslipidemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Fluvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014