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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00289029 |
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Date of registration:
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07/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Two Iodinated Contrast Agents in Renally Impaired Patients Undergoing Cardiac Angiography
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Scientific title:
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Visipaque and Isovue in Cardiac Angiography in Renally Impaired Patients |
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Date of first enrolment:
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July 2005 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00289029 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Marie Morris |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bracco Diagnostics, Inc |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Referred for cardiac angiography; with a documented predose eGFR of greater than or
equal to 20 and less than 60 mL/min/1.73m2
Exclusion Criteria:
- Unstable renal function; concurrent administration of nephrotoxic drugs, undergoing
dialysis
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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CIN
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Intervention(s)
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Drug: Iopamidol 370 mgI/mL
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Primary Outcome(s)
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Increase in SCr at 48-72 hours post dose
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Secondary Outcome(s)
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Decrease in eGFR at 48-72 hours post dose; occurrence of adverse events; effect on heart rate
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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