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

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	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 Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value * 100

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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in LDL-C after six week of treatment
Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group
Percent Change in HDL-C [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment
Percent Change in Non-HDL-C at 12 Weeks [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Percent change in non-HDL-C at 12 weeks
Percent Change in Triglycerides (TG) [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Percent change in tryglycerides (TG) after 12 weeks of treatment
Percent Change in Total Cholesterol (TC) [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Percent change from baseline in total cholesteral after 12 weeks of treatment
Percent Change in Apolipoprotein A-1 (ApoA-1) [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Percent change in ApoA-1 after 12 weeks of treatment
Percent Change in Apolipoprotein B (ApoB) [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Percent change in ApoB after 12 weeks of treatment
Percent Change in ApoB/ApoA-1 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment
Percent Change in LDL-C/HDL-C [ Time Frame: After 12 week of treatment ] [ Designated as safety issue: No ]
Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment
Percent Change in TC/HDL-C [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Percent change in the ratio of TC/HDL-C after 12 weeks of treatment
Percent Change in Non-HDL-C/HDL-C [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment

Enrollment:	173
Study Start Date:	July 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: rosuva 5 rosuvastatin 5 mg	Drug: Rosuvastatin oral Other Name: Nexium
Active Comparator: rosuva 10 rosuvastatin 10 mg	Drug: Rosuvastatin oral Other Name: Nexium
Active Comparator: rosuva 20 rosuvastatin 20 mg	Drug: Rosuvastatin oral Other Name: Nexium
Placebo Comparator: Placebo Placebo	Drug: Placebo oral
rosuva ol rosuvastatin open label	Drug: Rosuvastatin oral Other Name: Nexium

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
Chicoutimi, Quebec, Canada
Research Site
Laval, Quebec, Canada
Research Site
Sherbrook, Quebec, Canada
Netherlands
Research SIte
Amsterdam, Netherlands
Research Site
Eindhoven, Netherlands
Research Site
Groningen, Netherlands
Research Site
Hoorn, Netherlands
Research Site
Rotterdam, Netherlands
Research Site
Utrecht, Netherlands
Research SIte
Waalwijk, 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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Avis HJ, Hutten BA, Gagné C, Langslet G, McCrindle BW, Wiegman A, Hsia J, Kastelein JJ, Stein EA. Efficacy and safety of rosuvastatin therapy for children with familial hypercholesterolemia. J Am Coll Cardiol. 2010 Mar 16;55(11):1121-6.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00355615 History of Changes
Other Study ID Numbers:	D3561C00087, PLUTO
Study First Received:	July 20, 2006
Results First Received:	May 29, 2009
Last Updated:	August 29, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Heterozygous Familial Hypercholesterolemia

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

Rosuvastatin
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 February 09, 2012