Trials / Completed
CompletedNCT00826280
Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
A Phase 3b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Caffeine Intake on Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) in Subjects Administered Regadenoson
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 347 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Observe whether the administration of caffeine prior to regadenoson will affect the interpretation of test results in subjects with coronary artery disease (CAD) undergoing SPECT MPI
Detailed description
All subjects will undergo rest and stress scans. Those subjects who qualify by demonstrating at least 1 reversible defect, will undergo a third scan. All stress scans will involve the injection of regadenoson as the pharmacologic stress agent. Prior to the third scan, the subject will be administered blinded capsules of placebo or caffeine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | regadenoson | IV |
| DRUG | overencapsulated caffeine | oral |
| RADIATION | technetium | IV |
| DRUG | placebo | oral |
Timeline
- Start date
- 2009-03-24
- Primary completion
- 2010-07-15
- Completion
- 2010-07-15
- First posted
- 2009-01-22
- Last updated
- 2024-12-03
- Results posted
- 2011-10-21
Locations
25 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00826280. Inclusion in this directory is not an endorsement.