PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Familial Hypercholesterolemia
Intervention: Rosuvastatin (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Crestor Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary measure of efficacy in this study is percent change in LDL-C from baseline (Day 0) to the end of the 12-week double-blind treatment phase
Secondary outcome: 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 control rate based on achievement of LDL-C target of <110 mg/dL during double-blind dose treatment
Eligibility
Minimum age: 10 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Research Site, Hoorn, Netherlands
Research Site, Rotterdam, Netherlands
Research SIte, Amsterdam, Netherlands
Research SIte, Waalwijk, Netherlands
Research Site, Eindhoven, Netherlands
Research Site, Utrecht, Netherlands
Research Site, Groningen, Netherlands
Research Site, Oslo, Norway
Research Site, Cordoba, Spain
Research Site, Madrid, Spain
Research Site, Reus, Spain
Research Site, Los Angeles, California, United States
Research Site, Hyde Park, New York, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Hamilton, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Wexford, Pennsylvania, United States
Research Site, Laval, Quebec, Canada
Research Site, Chicoutimi, Quebec, Canada
Research Site, Sherbrook, Quebec, Canada
Additional Information
Starting date: June 2006
Last updated: July 3, 2007
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