PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

August 29, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Canada
        • Research Site
      • Laval, Quebec, Canada
        • Research Site
      • Sherbrook, Quebec, Canada
        • Research Site
  • Netherlands
      • 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
        • Research Site
  • Norway
      • Oslo, Norway
        • Research Site
  • Spain
      • Cordoba, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Reus, Spain
        • Research Site
  • United States
    • California
      • Los Angeles, California, United States
        • Research Site
    • New York
      • Hyde Park, New York, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
    • Pennsylvania
      • Wexford, Pennsylvania, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
oral
Active Comparator: rosuva 5
rosuvastatin 5 mg
Drug: Rosuvastatin
oral
Other Names:
  • Nexium
Active Comparator: rosuva 10
rosuvastatin 10 mg
Drug: Rosuvastatin
oral
Other Names:
  • Nexium
Active Comparator: rosuva 20
rosuvastatin 20 mg
Drug: Rosuvastatin
oral
Other Names:
  • Nexium
Other: rosuva ol
rosuvastatin open label
Drug: Rosuvastatin
oral
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value * 100
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Percent change from baseline in LDL-C after six week of treatment
6 weeks
Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment
Time Frame: 12 weeks
Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group
12 weeks
Percent Change in HDL-C
Time Frame: After 12 weeks of treatment
Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment
After 12 weeks of treatment
Percent Change in Non-HDL-C at 12 Weeks
Time Frame: After 12 weeks of treatment
Percent change in non-HDL-C at 12 weeks
After 12 weeks of treatment
Percent Change in Triglycerides (TG)
Time Frame: After 12 weeks of treatment
Percent change in tryglycerides (TG) after 12 weeks of treatment
After 12 weeks of treatment
Percent Change in Total Cholesterol (TC)
Time Frame: After 12 weeks of treatment
Percent change from baseline in total cholesteral after 12 weeks of treatment
After 12 weeks of treatment
Percent Change in Apolipoprotein A-1 (ApoA-1)
Time Frame: After 12 weeks of treatment
Percent change in ApoA-1 after 12 weeks of treatment
After 12 weeks of treatment
Percent Change in Apolipoprotein B (ApoB)
Time Frame: After 12 weeks of treatment
Percent change in ApoB after 12 weeks of treatment
After 12 weeks of treatment
Percent Change in ApoB/ApoA-1
Time Frame: After 12 weeks of treatment
Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment
After 12 weeks of treatment
Percent Change in LDL-C/HDL-C
Time Frame: After 12 week of treatment
Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment
After 12 week of treatment
Percent Change in TC/HDL-C
Time Frame: After 12 weeks of treatment
Percent change in the ratio of TC/HDL-C after 12 weeks of treatment
After 12 weeks of treatment
Percent Change in Non-HDL-C/HDL-C
Time Frame: After 12 weeks of treatment
Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment
After 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Crestor Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

July 20, 2006

First Submitted That Met QC Criteria

July 21, 2006

First Posted (Estimate)

July 24, 2006

Study Record Updates

Last Update Posted (Estimate)

August 31, 2011

Last Update Submitted That Met QC Criteria

August 29, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3561C00087
  • PLUTO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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