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Renal Safety of Iopamidol Versus Iodixanol During Coronary Angiography in Diabetic Patients

NCT00782639 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-01-26

Study results available
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Summary

The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with moderate-to-severe chronic kidney disease and diabetes mellitus undergoing cardiac angiography.

Conditions

Interventions

DRUG

Iopamidol injection 76%

Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution

DRUG

iodixanol

Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution

Sponsors & Collaborators

  • Bracco Diagnostics, Inc

    lead INDUSTRY

Principal Investigators

  • Alberto Spinazzi, M.D. · Bracco Diagnostics

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00782639 on ClinicalTrials.gov