drugset / Trial / NCT01252810
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
Phase 2
Completed
284 enrolled
GE Healthcare
Biomedical Systems · collabMedpace, Inc. · collabRules-Based Medicine, Inc. · collabi3 Statprobe · collab
RandomizedParallel-groupDouble-blindDiagnostic
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.
Timeline
- Start
- 2010-11
- Primary completion
- 2012-12
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ioforminol | Diagnostic / imaging agent | 320 mg/ml | Intravenous |
| Subject | Iopamidol | Diagnostic / imaging agent | 370 mg/ml | Intravenous |