Status:
COMPLETED
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
i3 Statprobe
Conditions:
Drug Safety
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopam...
Eligibility Criteria
Inclusion
- The subject is over 18 years old.
- Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care.
Exclusion
- The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
- The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period.
- The subject is pregnant or lactating.
- The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.
- The subject manifests thyrotoxicosis or is on dialysis.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT01475097
Start Date
October 1 2011
End Date
February 1 2013
Last Update
June 11 2014
Active Locations (1)
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1
GE Healthcare
Princeton, New Jersey, United States, 08540