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

NCT01475097 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2014-06-11

Study results available
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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

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.

Sponsors & Collaborators

  • i3 Statprobe

    collaborator INDUSTRY

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Lauren Lim, PharmD · GE Healthcare

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01475097 on ClinicalTrials.gov