PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
Public ClinicalTrials.gov record NCT00355615. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00355615
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 173 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2006
- Primary completion
- Jun 30, 2008
- Completion
- Jun 30, 2008
- Last update posted
- Aug 30, 2011
2006 – 2008
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Los Angeles | California | — | — |
| Research Site | Hyde Park | New York | — | — |
| Research Site | Cincinnati | Ohio | — | — |
| Research Site | Wexford | Pennsylvania | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
Recently updated Familial Hypercholesterolemia trials
Other public records listing Familial Hypercholesterolemia. Sorted by last update posted; newest first. Not a recommendation.
- NCT07653555: Cascade Testing In Identifying At-risk Family Members Of Individuals With Familial Hypercholesterolemia (FH) In PCP Not yet recruiting
- NCT04941599: 2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH) Recruiting
- NCT05348564: Comparing Direct vs Indirect Methods for Cascade Screening Recruiting
- NCT07470723: The ORIGIN-FH Study Recruiting
- NCT05238519: Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH) Active, not recruiting
- NCT06439654: Atlantic Lipid Lowering Treatment Optimization Program Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00355615, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 30, 2011 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00355615 live on ClinicalTrials.gov.