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NCT01618669 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,147
- Enrollment target
NCT01618669: Completed Phase 3 study, sponsored by Astellas Pharma Global Development.
NCT01618669 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 1,147 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01618669, a Phase 3 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,147 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson SPECT images without exercise.
Primary Outcome
SPECT scans were reviewed in a blinded fashion by 3 independent expert readers using the 17-segment model for standardized myocardial segmentation. At rest and stress, each segment was scored on a 0 (normal) to 4 (absent contrast/radiotracer uptake) scale by each of the 3 blinded readers according to the amount of contrast or radiotracer the myocardium in the segment absorbed. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a rever
Interventions
- DRUG Regadenoson
- PROCEDURE Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,147 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01618669 record still lists
NCT01618669 is an interventional study that assigns participants to a tested intervention. Its 1,147 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher).
The record links to 0 conditions, and to 2 interventions - of which Regadenoson is the first listed.
NCT01618669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01618669 about?
NCT01618669 is a clinical study titled "A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)". The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between tw...
What is the current status of trial NCT01618669?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,147 participants. The study started on 2012-06. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01618669?
The interventions under investigation include: Regadenoson (DRUG), Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) (PROCEDURE).
Who is sponsoring clinical trial NCT01618669?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01618669's enrollment target sits among peer trials
1,147 242nd of 2000 higher than 1,759 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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