Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when
compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either
chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive
heart failure (CHF) NYHA Class III or greater, who are referred for a coronary
catheterization procedure with or without PCI.
Phase:
Phase 2
Details
Lead Sponsor:
GE Healthcare
Collaborators:
Biomedical Systems i3 Statprobe Medpace, Inc. Rules-Based Medicine, Inc.