PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00355615

Purpose

The primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind treatment period.

Condition	Intervention	Phase
Familial Hypercholesterolemia	Drug: Rosuvastatin	Phase III

Genetics Home Reference related topics: 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: Rosuvastatin Rosuvastatin calcium Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIIb, Efficacy, and Safety Study of Rosuvastatin in Children 10-17 Years of Age With Heterozygous Familial Hypercholesterolemia: a 12-Week, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study With a 40-Week, Open-Label, Follow-up

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary measure of efficacy in this study is percent change in LDL-C from baseline (Day 0) to the end of the 12-week double-blind treatment phase

Secondary Outcome Measures:

Percent change in LDL-C and other lipid parameters from baseline to Week 6, and at end of double-blind dose treatment phase (Week 12)
Percent control rate based on achievement of LDL-C target of <110 mg/dL during double-blind dose treatment

Estimated Enrollment:	200
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female (at least 1 year post-menarche) children and adolescents (aged 10 –17 years) with heterozygous familial hypercholesterolemia (HeFH)

Exclusion Criteria:

Certain medical conditions and lab test results
History of a reaction to rosuvastatin or other statin drugs
Use of specified disallowed medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355615

Locations

United States, California
Research Site
Los Angeles, California, United States
United States, New York
Research Site
Hyde Park, New York, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Pennsylvania
Research Site
Wexford, Pennsylvania, United States
Canada, Ontario
Research Site
Hamilton, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Laval, Quebec, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Sherbrook, Quebec, Canada
Netherlands
Research Site
Hoorn, Netherlands
Research Site
Rotterdam, Netherlands
Research SIte
Amsterdam, Netherlands
Research SIte
Waalwijk, Netherlands
Research Site
Eindhoven, Netherlands
Research Site
Utrecht, Netherlands
Research Site
Groningen, Netherlands
Norway
Research Site
Oslo, Norway
Spain
Research Site
Cordoba, Spain
Research Site
Madrid, Spain
Research Site
Reus, Spain

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Crestor Medical Science Director, MD

AstraZeneca

More Information

Study ID Numbers:	D3561C00087, PLUTO
Study First Received:	July 20, 2006
Last Updated:	July 3, 2007
ClinicalTrials.gov Identifier:	NCT00355615
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Heterozygous Familial Hypercholesterolemia

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors
Hypercholesterolemia, autosomal dominant
Hyperlipidemias
Metabolic Diseases
Hyperlipoproteinemia Type II
Metabolism, Inborn Errors
Rosuvastatin

Genetic Diseases, Inborn
Metabolic disorder
Hypercholesterolemia
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009