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NCT00162032 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
A Phase 3 study, sponsored by Lantheus Medical Imaging.
- Completed
- Registry status
- Phase 3
- Development phase
- 445
- Enrollment target
NCT00162032: Completed Phase 3 study, sponsored by Lantheus Medical Imaging.
NCT00162032 is a Phase 3 study that has completed, run by Lantheus Medical Imaging. The registered enrollment target is 445 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00162032, a Phase 3 study, has completed, sponsored by Lantheus Medical Imaging.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 445 participants
- Enrollment target
Study Summary
Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.
Primary Outcome
The proportion of all patients who experienced cardiac events among patients with abnormal (SSS \>=4, high risk) and normal (SSS \<4, low risk) Cardiolite MPI scans during the follow-up period. A log-rank statistic (2-sided, alpha = 0.05) was computed to compare cardiac event-free survival in the high risk and low risk groups. The cardiac event rate is the cumulative event rate based on a Kaplan-Meier estimate conditional on the SPECT MPI score result.
Interventions
- DRUG Sestamibi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 445 participants |
| Start Date | 2005-08 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
What the finished NCT00162032 record still lists
NCT00162032 is an interventional study that assigns participants to a tested intervention. The registered 445 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 (42% lower).
The record links to 0 conditions, and to 1 intervention - of which Sestamibi is the first listed.
NCT00162032 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00162032 about?
NCT00162032 is a clinical study titled "A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease". Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.
What is the current status of trial NCT00162032?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 445 participants. The study started on 2005-08. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00162032?
The interventions under investigation include: Sestamibi (DRUG).
Who is sponsoring clinical trial NCT00162032?
This trial is sponsored by Lantheus Medical Imaging, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00162032's enrollment target sits among peer trials
445 864th of 2000 higher than 1,137 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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