Trials / Completed
CompletedNCT00355615
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 173 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rosuvastatin | oral |
| DRUG | Placebo | oral |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2008-07-01
- Completion
- 2008-07-01
- First posted
- 2006-07-24
- Last updated
- 2011-08-31
- Results posted
- 2009-07-20
Locations
20 sites across 5 countries: United States, Canada, Netherlands, Norway, Spain
Source: ClinicalTrials.gov record NCT00355615. Inclusion in this directory is not an endorsement.