| Trial ID: | L0529 |
| Source ID: | NCT01252810
|
| Associated Drug: |
Ge-145
|
| Title: |
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01252810/results
|
| Conditions: |
Chronic Renal Insufficiency|Diabete Mellitus|Congestive Heart Failure
|
| Interventions: |
DRUG: GE-145
|
| Outcome Measures: |
Primary: Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader., Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales., After the imaging date for either Ioforminol or Iopamidol. | Secondary: To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration, To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration of GE-145 or iopamidol. To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol. Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects., Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.|Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections, Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI)., 2, 6 and 24 hours post Ioforminol and Iopamidol adminstration
|
| Sponsor/Collaborators: |
Sponsor: GE Healthcare | Collaborators: i3 Statprobe|Medpace, Inc.|Biomedical Systems|Rules-Based Medicine, Inc.
|
| Gender: |
ALL
|
| Age: |
OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
284
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
|
| Start Date: |
2010-11
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| Completion Date: |
2012-12
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| Results First Posted: |
2014-05-02
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| Last Update Posted: |
2018-08-29
|
| Locations: |
GE Healthcare, Princeton, New Jersey, 08540, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01252810
|
