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Binodenoson (an experimental drug) and adenosine (an FDA-approved drug that is currently used by doctors) are used to increase blood flow to the heart just like when a person exercises on a treadmill. Using imaging techniques, this increased blood flow can help determine if areas of the heart are not getting enough blood and oxygen during exercise. The purpose of the study is to determine if binodenoson is as good as adenosine in determining if there are areas of the heart not getting enough oxygen when blood flow to the heart is increased.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| binodenoson then adenosine | Other | binodenoson (experimental); adenosine (active comparator) |
|
| adenosine then binodenoson | Other | adenosine (active comparator); binodenoson (experimental) |
|
| adenosine then adenosine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| binodenoson | Drug | 30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summed difference in binodenoson and adenosine reader-generated Summed Difference Scores | 2 to 7 days apart | |
| Summed difference in adenosine- and adenosine-2 reader-generated Summed Difference Scores | 2 to 7 days apart | |
| Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores | 2 to 7 days apart | |
| Extreme discrepancies in adenosine- and adenosine-2 reader-generated Summed Difference Scores | 2 to 7 days apart |
| Measure | Description | Time Frame |
|---|---|---|
| Categorized reader-generated Summed Difference Scores (binodenoson and adenosine) | 2 to 7 days apart | |
| Categorized reader-generated Summed Difference Scores (adenosine-1 and adenosine-2) | 2 to 7 days apart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert L. Rolleri, Pharm.D. | King Pharmaceuticals is now a wholly owned subsidiary of Pfizer | Study Director |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| C101949 | binodenoson |
| D000241 | Adenosine |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| adenosine | Drug | 30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute) |
|
| Difference in reader-generated Summed Stress Scores (binodenoson and adenosine) | 2 to 7 days apart |
| Difference in reader-generated Summed Stress Scores (adenosine-1 and adenosine-2) | 2 to 7 days apart |
| Extreme discrepant reader-generated Summed Stress Scores (binodenoson and adenosine) | 2 to 7 days apart |
| Extreme discrepant reader-generated Summed Stress Scores (adenosine-1 and adenosine-2) | 2 to 7 days apart |
| Categorized reader-generated Summed Stress Scores (binodenoson and adenosine) | 2 to 7 days apart |
| Categorized reader-generated Summed Stress Scores (adenosine-1 and adenosine-2) | 2 to 7 days apart |
| Sensitivity compared to coronary angiography | angiography obtained up to 60 days post-image |
| Specificity compared to coronary angiography | angiography obtained up to 60 days post-image |
| Sensitivity compared to clinical endpoint | clinical endpoint obtained up to 60 days post-image |
| Specificity compared to clinical endpoint | clinical endpoint obtained up to 60 days post-image |
| Incidence of second- or third-degree AV block | 0 to 60 minutes after start of study drug administration |
| Patient-rated overall symptom bother | 1 hour post-dosing |
| Patient preference for pharmacologic stress agent | 1 to 4 days following 2nd procedure |
| Incidence of flushing | 0 to 60 minutes after start of study drug administration |
| Patient-rated intensity of flushing | 0 to 60 minutes after start of study drug administration |
| Incidence of chest pain | 0 to 60 minutes after start of study drug administration |
| Patient-rated intensity of chest pain | 0 to 60 minutes after start of study drug administration |
| Incidence of dyspnea | 0 to 60 minutes after start of study drug administration |
| Patient-rated intensity of dyspnea | 0 to 60 minutes after start of study drug administration |
| Incidence of nausea | 0 to 60 minutes after start of study drug administration |
| Patient-rated intensity of nausea | 0 to 60 minutes after start of study drug administration |
| Incidence of headache | 0 to 60 minutes after start of study drug administration |
| Patient-rated intensity of headache | 0 to 60 minutes after start of study drug administration |
| Incidence of abdominal discomfort | 0 to 60 minutes after start of study drug administration |
| Patient-rated intensity of abdominal discomfort | 0 to 60 minutes after start of study drug administration |
| Incidence of dizziness | 0 to 60 minutes after start of study drug administration |
| Patient-rated intensity of dizziness | 0 to 60 minutes after start of study drug administration |
| Overall incidence of adverse events | up to 7 days post-dosing |
| Peak change in heart rate | 0 to 60 minutes after start of study drug administration |
| Peak change in systolic blood pressure | 0 to 60 minutes after start of study drug administration |
| Peak change in diastolic blood pressure | 0 to 60 minutes after start of study drug administration |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |