Phase 4
N=255
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
Drug Safety
Bottom Line
View on ClinicalTrials.gov: NCT01475097 ↗Enrolled (actual)
255
Serious AEs
1.6%
Results posted
Apr 2014
Primary outcome: Primary: Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography — 53; 92; 48; 82 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Iodixanol (Drug); Iopamidol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography |
53; 92; 48; 82; 5; 21 | — |
| SECONDARY Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. |
109; 103; 16; 19; 1; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- The subject is over 18 years old.
- Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01475097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.