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NCT01475097 · ClinicalTrials.gov registry record · Phase 4
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
A Phase 4 study of Drug Safety, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 4
- Development phase
- 255
- Enrollment target
- 1
- Study location
NCT01475097: Completed Phase 4 study of Drug Safety, sponsored by GE Healthcare.
NCT01475097 is a Phase 4 study of Drug Safety that has completed, run by GE Healthcare. The registered enrollment target is 255 participants, above the 40-participant average among 4 other Drug Safety trials with a reported enrollment target (538% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01475097, a Phase 4 study of Drug Safety, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 255 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.
Conditions Studied
Interventions
- DRUG Iopamidol
- DRUG Iodixanol
Study Locations (1)
New Jersey
- GE Healthcare - Princeton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-02 |
| Phase | Phase 4 |
What the finished NCT01475097 record still lists
NCT01475097 is an interventional study that assigns participants to a tested intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, above the 40-participant average among 4 other Drug Safety trials with a reported enrollment target (538% higher).
The record links to 1 condition, with Drug Safety appearing as the primary indexed condition, and to 2 interventions - of which Iopamidol is the first listed.
NCT01475097 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT01475097 about?
NCT01475097 is a clinical study titled "Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography". 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.
What is the current status of trial NCT01475097?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 255 participants. The study started on 2011-10. Estimated completion is 2013-02.
What conditions does trial NCT01475097 study?
This clinical trial studies the following conditions: Drug Safety.
What interventions are being tested in trial NCT01475097?
The interventions under investigation include: Iopamidol (DRUG), Iodixanol (DRUG).
Who is sponsoring clinical trial NCT01475097?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01475097 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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