NCT01475097

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

A Phase 4 Randomized, Double-blind Study Comparing Patient Comfort and Safety Between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing Peripheral Arteriography

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Drug Safety

Interventions

Type	Name	Description
DRUG	Iodixanol	Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
DRUG	Iopamidol	Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-11-21
• Last updated: 2014-06-11
• Results posted: 2014-04-15

Locations

1 site across 1 country: United States