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PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

NCT00355615 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2011-08-31

Study results available
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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.

Conditions

  • Familial Hypercholesterolemia

Interventions

DRUG

Rosuvastatin

oral

DRUG

Placebo

oral

Sponsors & Collaborators

Principal Investigators

  • Crestor Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Canada
  • Netherlands
  • Norway
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00355615 on ClinicalTrials.gov