PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

Completed · Phase 3 · Has a placebo group

Conditions studied: Familial Hypercholesterolemia

In brief

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.

Key facts

Study ID: NCT00355615
Run by: AstraZeneca
People needed: 173
Starts: 2006-07-01
Expected to finish: 2008-07-01
Last updated by the study team: 2011-08-31

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)

You may not qualify if…

Certain medical conditions and lab test results
History of a reaction to rosuvastatin or other statin drugs
Use of specified disallowed medications

Where it is running

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

Full record on ClinicalTrials.gov

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