Status:
COMPLETED
Safety and Efficacy of SeeMore (TM) in Heart Patients
Lead Sponsor:
Eagle Vision Pharmaceutical Corp.
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will examine the safety and effectiveness of a manganese-based agent called SeeMore (EVP 1001-1 Injection) for enhancing magnetic resonance imaging (MRI) in patients who have previously had...
Detailed Description
This is a Phase II open-label, baseline-controlled study. Approximately 10 adult male or nonpregnant female patients known to have had a myocardial infarct (nonacute) are intended to be enrolled at th...
Eligibility Criteria
Inclusion
- be at least 18 years of age.
- if female, be nonpregnant as evidenced by a serum pregnancy test and using a medically-approved method of birth control, or post-menopausal or surgically sterile
- provide written informed consent after having received oral and written information about the study
- be in stable health based on medical history, examination and tests
- have potassium, calcium and hematocrit values within normal limits
- have a prior known myocardial infarction
Exclusion
- have a positive pregnancy test (females)
- received an investigational drug or device within 30 days prior to administration of SeeMore™
- have known hypersensitivity to ondansetron or other selective serotonin 5HT3 receptor blockers
- have a history of drug abuse or alcoholism
- have had a myocardial infarct, unstable angina, stroke of transient ischemic attack (TIA) within the past six months
- are taking a digitalis preparation or calcium channel blocker
- have arrhythmias requiring medication
- have a prolonged PR interval, history of an atrioventricular conduction disorder or sick sinus syndrome
- have a prolonged QTc interval, ventricular arrhythmia or history of torsades
- have NYHA Grade III or IV heart failure
- have abnormal liver function tests or a history of liver disease
- have uncontrolled hypertension
- have potassium, calcium or hematocrit values outside normal limits
- have altered a prescription medication within 14 days or an over-the-counter medication within 7 days
- are noncompliant or otherwise unlikely to perform as required by the protocol
- if a new cardiac arrhythmia develops prior to the scheduled time for SeeMore™ administration, SeeMore™ will be withheld.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00881075
Start Date
June 1 2008
End Date
March 1 2012
Last Update
February 4 2016
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