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

NCT01252810 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2018-08-29

Study results available
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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

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.

Sponsors & Collaborators

  • i3 Statprobe

    collaborator INDUSTRY

  • Medpace, Inc.

    collaborator INDUSTRY

  • Biomedical Systems

    collaborator INDUSTRY

  • Rules-Based Medicine, Inc.

    collaborator INDUSTRY

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Rubin Sheng, M.D. · GE Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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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 NCT01252810 on ClinicalTrials.gov