| Trial ID: | L0701 |
| Source ID: | NCT00908310
|
| Associated Drug: |
Omniscan
|
| Title: |
Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00908310/results
|
| Conditions: |
Chronic Kidney Disease|Renal Insufficiency
|
| Interventions: |
DRUG: Omniscan
|
| Outcome Measures: |
Primary: Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF)., Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN., Greater than or equal to 7 days post contrast administration. |
|
| Sponsor/Collaborators: |
Sponsor: GE Healthcare | Collaborators: i3 Statprobe
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
213
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
|
| Start Date: |
2009-05
|
| Completion Date: |
2013-09
|
| Results First Posted: |
2014-07-17
|
| Last Update Posted: |
2014-07-17
|
| Locations: |
GE Healthcare, Princeton, New Jersey, 08540, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00908310
|
