Status:
TERMINATED
Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
PPD Development, LP
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to see whether apadenoson is as effective as adenosine when used as a pharmacological stress agent in myocardial SPECT-Imaging to detect defects in the supply of blood to ...
Detailed Description
Adenosine is an effective vasodilator used in SPECT-Myocardial Perfusion Imaging (SPECT-MPI). However, it produces transient symptoms that are poorly tolerated by most subjects. PGxHealth has designed...
Eligibility Criteria
Inclusion
- High pretest probability of CAD based on the ACC/AHA guidelines for relative risk, or past medical h/o CAD
Exclusion
- Ingestion of a caffeinated or methylxanthine food substance (e.g. chocolate, cocoa) within 24 hours before receiving apadenoson or adenosine
- Treatment with dipyridamole within 24 hours, or theophylline, aminophylline, or pentoxifylline within 72 hours (or 4 half-lives, whichever is longer) prior to receiving apadenoson or adenosine
- Acute MI, new onset of ischemia or PCI within 30 days prior to SPECT-MPI at either Period 1 or Period 2; or CABG within 90 days prior to SPECT-MPI at either Period 1 or Period 2
- Active severe asthma or severe chronic obstructive pulmonary disease (COPD) which, in the Investigator's opinion, places the subject at risk for severe bronchoconstriction
- History or evidence of clinically significant cardiac condition and rhythm disorder, in the absence of a functioning permanently implanted pacemaker
- Hemodynamically significant valvular disease, outflow tract obstruction, or uncontrolled severe hypertension
- Current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug
- Subject with past medical history of hepatitis B or C, or recent hepatitis A
- Pretreatment hypotension (systolic BP \< 90 mm Hg) or tachycardia (HR \> 100 bpm)
- Known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
863 Patients enrolled
Trial Details
Trial ID
NCT00990327
Start Date
November 1 2009
End Date
April 1 2012
Last Update
May 1 2012
Active Locations (122)
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1
Forest Investigative Site 152
Birmingham, Alabama, United States, 35294
2
Forest Investigative Site 250
Mobile, Alabama, United States, 36608
3
Forest Investigative Site 223
Phoenix, Arizona, United States, 85006
4
Forest Investigative Site 191
Phoenix, Arizona, United States, 85020