Trials / Completed
CompletedNCT01618669
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 3b, Open-Label, Parallel Group, Randomized, Multicenter 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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,147 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Regadenoson | Administered as an intravenous (IV) bolus |
| PROCEDURE | Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2012-06-13
- Last updated
- 2016-02-08
- Results posted
- 2016-02-08
Locations
69 sites across 4 countries: United States, Argentina, Peru, Puerto Rico
Source: ClinicalTrials.gov record NCT01618669. Inclusion in this directory is not an endorsement.