Clinical trial NCT00355615: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Familial Hypercholesterolemia
Keywords: Heterozygous Familial Hypercholesterolemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-07-24
Enrollment: 173
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase
timeFrame: 12 weeks
Secondary outcomes:
measure: 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)
timeFrame: 6 weeks
measure: Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment
timeFrame: 12 weeks
measure: Percent Change in HDL-C
timeFrame: After 12 weeks of treatment
measure: Percent Change in Non-HDL-C at 12 Weeks
timeFrame: After 12 weeks of treatment
measure: Percent Change in Triglycerides (TG)
timeFrame: After 12 weeks of treatment
measure: Percent Change in Total Cholesterol (TC)
timeFrame: After 12 weeks of treatment
measure: Percent Change in Apolipoprotein A-1 (ApoA-1)
timeFrame: After 12 weeks of treatment
measure: Percent Change in Apolipoprotein B (ApoB)
timeFrame: After 12 weeks of treatment
measure: Percent Change in ApoB/ApoA-1
timeFrame: After 12 weeks of treatment
measure: Percent Change in LDL-C/HDL-C
timeFrame: After 12 week of treatment
measure: Percent Change in TC/HDL-C
timeFrame: After 12 weeks of treatment
measure: Percent Change in Non-HDL-C/HDL-C
timeFrame: After 12 weeks of treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Hyde Park
country: United States
facility: Research Site
state: New York
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Wexford
country: United States
facility: Research Site
state: Pennsylvania
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Research Site
state: Quebec
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Sherbrook
country: Canada
facility: Research Site
state: Quebec
city: Amsterdam
country: Netherlands
facility: Research SIte
city: Eindhoven
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Hoorn
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Waalwijk
country: Netherlands
facility: Research SIte
city: Oslo
country: Norway
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Reus
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Crestor Medical Science Director, MD
role: STUDY_DIRECTOR
References:
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.