Status:
COMPLETED
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
Lead Sponsor:
AstraZeneca
Conditions:
Familial Hypercholesterolemia
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)
Exclusion
- Certain medical conditions and lab test results
- History of a reaction to rosuvastatin or other statin drugs
- Use of specified disallowed medications
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00355615
Start Date
July 1 2006
End Date
July 1 2008
Last Update
August 31 2011
Active Locations (20)
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1
Research Site
Los Angeles, California, United States
2
Research Site
Hyde Park, New York, United States
3
Research Site
Cincinnati, Ohio, United States
4
Research Site
Wexford, Pennsylvania, United States