CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 284 enrolled
Drug / intervention
GE-145drug
Likely dose
GE-145 320 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01252810
NCT01252810Phase 2Completed
CompareCT.gov

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

GE Healthcare·interventional·Posted Dec 3, 2010·Updated Aug 29, 2018

In Brief

A Phase 2 clinical trial evaluating GE-145 for Chronic Renal Insufficiency and 2 related conditions. Completed, enrolled 284 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Renal Insufficiency, Diabete Mellitus, Congestive Heart Failure
CountriesUnited States
Collaboratorsi3 Statprobe, Medpace, Inc., Biomedical Systems, Rules-Based Medicine, Inc.

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 3, 2010
Enrollment StartNov 1, 2010
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.6 years ago

Interventions

GE-145drug

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