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NCT00355615 · ClinicalTrials.gov registry record · Phase 3
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 173
- Enrollment target
NCT00355615: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00355615 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 173 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00355615, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 173 participants
- Enrollment target
Study 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.
Primary Outcome
Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value \* 100
Interventions
- DRUG Placebo
- DRUG Rosuvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
What the finished NCT00355615 record still lists
NCT00355615 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00355615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00355615 about?
NCT00355615 is a clinical study titled "PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin". 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.
What is the current status of trial NCT00355615?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2006-07. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00355615?
The interventions under investigation include: Placebo (DRUG), Rosuvastatin (DRUG).
Who is sponsoring clinical trial NCT00355615?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00355615's enrollment target sits among peer trials
173 1445th of 2000 higher than 553 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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