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The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMB-1018972 200mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMB-1018972 | Drug | Modified release (MR) oral tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs | Randomization through Week 10 Safety Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of ischemic segments during hyperemia (ischemia defined as absolute MBF ≤2.0 ml/kg/min) as measured by adenosine stress 15O-H2O PET | Ischemia score defined on the basis of absolute hyperemic MBF as: (1) MBF 2.0-2.3 ml/g/min; (2) 1.7- 2.0 ml/g/min; (3) MBF <1.7 ml/g/min | Baseline through Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor, MD | Imbria Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imbria Investigational Site | Aarhus | Denmark | ||||
| Imbria Investigational Site |
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| Placebo |
| Drug |
Matching oral tablet |
|
| Change in total ischemia burden measured as ischemia score summed across all segments as measured by adenosine stress 15O-H2O PET |
| Baseline through Week 8 |
| Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET | Baseline through Week 8 |
| Turku |
| Finland |
| Imbria Investigational Site | Uppsala | Sweden |
| ID | Term |
|---|---|
| D007511 | Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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