Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography

Completed · Phase 4

Conditions studied: Drug Safety

In brief

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), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.

Key facts

Study ID

NCT01475097

Run by

GE Healthcare

People needed

255

Starts

2011-10-01

Expected to finish

2013-02-01

Last updated by the study team

2014-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is over 18 years old.
• Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care.

You may not qualify if…

• 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.

Where it is running

• GE Healthcare — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.