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PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

Primary Purpose

Familial Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rosuvastatin
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Familial Hypercholesterolemia focused on measuring Heterozygous Familial Hypercholesterolemia

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
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  • Research SIte
  • Research Site
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  • Research SIte
  • Research Site
  • Research Site
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  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Other

Arm Label

rosuva 5

rosuva 10

rosuva 20

Placebo

rosuva ol

Arm Description

rosuvastatin 5 mg

rosuvastatin 10 mg

rosuvastatin 20 mg

Placebo

rosuvastatin open label

Outcomes

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
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)
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
Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group
Percent Change in HDL-C
Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment
Percent Change in Non-HDL-C at 12 Weeks
Percent change in non-HDL-C at 12 weeks
Percent Change in Triglycerides (TG)
Percent change in tryglycerides (TG) after 12 weeks of treatment
Percent Change in Total Cholesterol (TC)
Percent change from baseline in total cholesteral after 12 weeks of treatment
Percent Change in Apolipoprotein A-1 (ApoA-1)
Percent change in ApoA-1 after 12 weeks of treatment
Percent Change in Apolipoprotein B (ApoB)
Percent change in ApoB after 12 weeks of treatment
Percent Change in ApoB/ApoA-1
Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment
Percent Change in LDL-C/HDL-C
Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment
Percent Change in TC/HDL-C
Percent change in the ratio of TC/HDL-C after 12 weeks of treatment
Percent Change in Non-HDL-C/HDL-C
Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment

Full Information

First Posted
July 20, 2006
Last Updated
August 29, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00355615
Brief Title
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hypercholesterolemia
Keywords
Heterozygous Familial Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rosuva 5
Arm Type
Active Comparator
Arm Description
rosuvastatin 5 mg
Arm Title
rosuva 10
Arm Type
Active Comparator
Arm Description
rosuvastatin 10 mg
Arm Title
rosuva 20
Arm Type
Active Comparator
Arm Description
rosuvastatin 20 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
rosuva ol
Arm Type
Other
Arm Description
rosuvastatin open label
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Nexium
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase
Description
Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value * 100
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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)
Description
Percent change from baseline in LDL-C after six week of treatment
Time Frame
6 weeks
Title
Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment
Description
Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group
Time Frame
12 weeks
Title
Percent Change in HDL-C
Description
Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment
Time Frame
After 12 weeks of treatment
Title
Percent Change in Non-HDL-C at 12 Weeks
Description
Percent change in non-HDL-C at 12 weeks
Time Frame
After 12 weeks of treatment
Title
Percent Change in Triglycerides (TG)
Description
Percent change in tryglycerides (TG) after 12 weeks of treatment
Time Frame
After 12 weeks of treatment
Title
Percent Change in Total Cholesterol (TC)
Description
Percent change from baseline in total cholesteral after 12 weeks of treatment
Time Frame
After 12 weeks of treatment
Title
Percent Change in Apolipoprotein A-1 (ApoA-1)
Description
Percent change in ApoA-1 after 12 weeks of treatment
Time Frame
After 12 weeks of treatment
Title
Percent Change in Apolipoprotein B (ApoB)
Description
Percent change in ApoB after 12 weeks of treatment
Time Frame
After 12 weeks of treatment
Title
Percent Change in ApoB/ApoA-1
Description
Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment
Time Frame
After 12 weeks of treatment
Title
Percent Change in LDL-C/HDL-C
Description
Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment
Time Frame
After 12 week of treatment
Title
Percent Change in TC/HDL-C
Description
Percent change in the ratio of TC/HDL-C after 12 weeks of treatment
Time Frame
After 12 weeks of treatment
Title
Percent Change in Non-HDL-C/HDL-C
Description
Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment
Time Frame
After 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crestor Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Hyde Park
State/Province
New York
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Wexford
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Chicoutimi
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Sherbrook
State/Province
Quebec
Country
Canada
Facility Name
Research SIte
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Eindhoven
Country
Netherlands
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Hoorn
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
Facility Name
Research Site
City
Utrecht
Country
Netherlands
Facility Name
Research SIte
City
Waalwijk
Country
Netherlands
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Cordoba
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Reus
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20223367
Citation
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.
Results Reference
derived

Learn more about this trial

PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

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