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Sponsored by: |
Point Biomedical |
---|---|
Information provided by: | Point Biomedical |
ClinicalTrials.gov Identifier: | NCT00594698 |
The purpose of this study is to evaluate preparation and administration of PB127, echocardiographic images obtained during PB127 administration, and evaluate the safety of PB127.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Drug: PB127 for injectable suspension |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Familiarization and Safety Study of Myocardial Perfusion Contrast Echocardiography With PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease |
Enrollment: | 150 |
Study Start Date: | February 2002 |
Study Completion Date: | September 2003 |
Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
The primary objectives of this clinical trial are:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Known hypersensitivity or known contraindication to
History of:
Liver disease characterized by one or more of the following:
Significant valvular disease
Study Director: | Alexander Ehlgen, MD, PhD | POINT Biomedical Corp. |
Responsible Party: | POINT Biomedical Corp. ( Tom Ottobonie, PhD/Chief Operating Officer ) |
Study ID Numbers: | 127-005 |
Study First Received: | January 4, 2008 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00594698 |
Health Authority: | United States: Food and Drug Administration |
Perfusion Echocardiography Cardiac angiography SPECT |
Arterial Occlusive Diseases Coronary Disease Methamphetamine Heart Diseases Myocardial Ischemia |
Vascular Diseases Amphetamine Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |