PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Rosuvastatin Calcium

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