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Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography

NCT01255722 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2015-12-16

Study results available
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Summary

The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).

Conditions

Interventions

DRUG

iobitridol

single IV injection

DRUG

iopromide

Single IV injection

DRUG

iomeprol

Single IV injection

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Martin HOFFMANN, MD · Kantonsspital Lucerne- Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • France
  • Germany
  • Italy
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT01255722 on ClinicalTrials.gov