PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

Familial Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355615
• Other study ID #: D3561C00087
• Secondary ID: PLUTO
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2006
• Last updated: August 29, 2011
• Start date: July 2006
• Est. completion date: July 2008

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Drug:
• Rosuvastatin
oral
• Placebo
oral

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks	No
Secondary	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	6 weeks	No
Secondary	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	12 weeks	No
Secondary	Percent Change in HDL-C	Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment	After 12 weeks of treatment	No
Secondary	Percent Change in Non-HDL-C at 12 Weeks	Percent change in non-HDL-C at 12 weeks	After 12 weeks of treatment	No
Secondary	Percent Change in Triglycerides (TG)	Percent change in tryglycerides (TG) after 12 weeks of treatment	After 12 weeks of treatment	No
Secondary	Percent Change in Total Cholesterol (TC)	Percent change from baseline in total cholesteral after 12 weeks of treatment	After 12 weeks of treatment	No
Secondary	Percent Change in Apolipoprotein A-1 (ApoA-1)	Percent change in ApoA-1 after 12 weeks of treatment	After 12 weeks of treatment	No
Secondary	Percent Change in Apolipoprotein B (ApoB)	Percent change in ApoB after 12 weeks of treatment	After 12 weeks of treatment	No
Secondary	Percent Change in ApoB/ApoA-1	Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment	After 12 weeks of treatment	No
Secondary	Percent Change in LDL-C/HDL-C	Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment	After 12 week of treatment	No
Secondary	Percent Change in TC/HDL-C	Percent change in the ratio of TC/HDL-C after 12 weeks of treatment	After 12 weeks of treatment	No
Secondary	Percent Change in Non-HDL-C/HDL-C	Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment	After 12 weeks of treatment	No