Skip to main content
OpenTrials
Completed

NCT Number: NCT00355615

PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Familial Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

oral

Other names: Nexium

Placebo

Drug

oral

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Percent Change in Triglycerides (TG)

    Time frame: After 12 weeks of treatment

    Percent change in tryglycerides (TG) after 12 weeks of treatment

  6. 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

  7. 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

  8. Percent Change in Apolipoprotein B (ApoB)

    Time frame: After 12 weeks of treatment

    Percent change in ApoB after 12 weeks of treatment

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 24, 2006
Registry last updated
Aug 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.