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PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

NCT ID: NCT00355615

Last Updated: 2011-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Familial Hypercholesterolemia

Keywords

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Heterozygous Familial Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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rosuva 5

rosuvastatin 5 mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

oral

rosuva 10

rosuvastatin 10 mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

oral

rosuva 20

rosuvastatin 20 mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

oral

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

rosuva ol

rosuvastatin open label

Group Type OTHER

Rosuvastatin

Intervention Type DRUG

oral

Interventions

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Rosuvastatin

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Crestor Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Los Angeles, California, United States

Site Status

Research Site

Hyde Park, New York, United States

Site Status

Research Site

Cincinnati, Ohio, United States

Site Status

Research Site

Wexford, Pennsylvania, United States

Site Status

Research Site

Hamilton, Ontario, Canada

Site Status

Research Site

Toronto, Ontario, Canada

Site Status

Research Site

Chicoutimi, Quebec, Canada

Site Status

Research Site

Laval, Quebec, Canada

Site Status

Research Site

Sherbrook, Quebec, Canada

Site Status

Research SIte

Amsterdam, , Netherlands

Site Status

Research Site

Eindhoven, , Netherlands

Site Status

Research Site

Groningen, , Netherlands

Site Status

Research Site

Hoorn, , Netherlands

Site Status

Research Site

Rotterdam, , Netherlands

Site Status

Research Site

Utrecht, , Netherlands

Site Status

Research SIte

Waalwijk, , Netherlands

Site Status

Research Site

Oslo, , Norway

Site Status

Research Site

Córdoba, , Spain

Site Status

Research Site

Madrid, , Spain

Site Status

Research Site

Reus, , Spain

Site Status

Countries

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United States Canada Netherlands Norway Spain

References

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Avis HJ, Hutten BA, Gagne 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. doi: 10.1016/j.jacc.2009.10.042.

Reference Type DERIVED
PMID: 20223367 (View on PubMed)

Other Identifiers

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PLUTO

Identifier Type: -

Identifier Source: secondary_id

D3561C00087

Identifier Type: -

Identifier Source: org_study_id