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Sponsored by: |
Point Biomedical |
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Information provided by: | Point Biomedical |
ClinicalTrials.gov Identifier: | NCT00584896 |
The purpose of this study is to determine if the use of PB127 with cardiac ultrasound assists in the diagnosis or exclusion of coronary artery disease.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Drug: PB127 for Injectable Suspension |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Clinical Trial to Assess Perfusion and Obstruction Identified by Non-Invasive Technology Using PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease II |
Estimated Enrollment: | 1000 |
Study Start Date: | October 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Exclusion Criteria:
Known hypersensitivity or known contraindication to:
Unstable cardiac status
Liver disease characterized by one or more of the following
Study Director: | Alexander Ehlgen, MD, PhD | POINT Biomedical Corp |
Responsible Party: | POINT Biomedical Corp. ( Tom Ottoboni, PhD/Chief Operating Officer ) |
Study ID Numbers: | 127-014 |
Study First Received: | December 20, 2007 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00584896 History of Changes |
Health Authority: | United States: Food and Drug Administration |
heart disease coronary artery disease echocardiogram ultrasound |
angiogram SPECT chest pain perfusion |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Pain Arteriosclerosis Ischemia Coronary Artery Disease Chest Pain |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |