NCT01252810

Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure

A Phase 2, Double-Blind, Randomized, Safety Study of GE-145 320 mg I/mL Injection Versus Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Artery Catheterization Procedure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Renal Insufficiency
• Diabete Mellitus
• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	GE-145	GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-12-03
• Last updated: 2018-08-29
• Results posted: 2014-05-02

Locations

1 site across 1 country: United States