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Gadobutrol Enhanced MRA of the Renal Arteries

NCT01344460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2015-08-26

Study results available
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Summary

Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).

Conditions

  • Renal Artery Obstruction

Interventions

DRUG

Gadobutrol (Gadovist, BAY86-4875)

a single bolus injection of approx. 0.1mmol/kg

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Colombia
  • Czechia
  • France
  • Germany
  • Poland
  • South Korea
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

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 NCT01344460 on ClinicalTrials.gov