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Completed Phase 3 Interventional Results available

Gadobutrol Enhanced MRA of the Renal Arteries

ClinicalTrials.gov ID: NCT01344460

Public ClinicalTrials.gov record NCT01344460. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 12:41 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Gadobutrol-enhanced Magnetic Resonance Angiography (MRA) After a Single Injection of 0.1 mmol/kg of Gadobutrol in Subjects With Known or Suspected Renal Artery Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT01344460
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
317 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2011
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012
Last update posted
Aug 25, 2015

2011 – 2012

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
14
Facility City State ZIP Site status
Not listed Tucson Arizona 85711
Not listed Los Angeles California 90033
Not listed Los Angeles California 90095
Not listed Orange California 92660
Not listed Jacksonville Florida 32209
Not listed Miami Florida 33136
Not listed Savannah Georgia 31406
Not listed Chicago Illinois 60611
Not listed Baltimore Maryland 21287
Not listed Durham North Carolina 27710
Not listed Providence Rhode Island 02903-4900
Not listed Memphis Tennessee 38104
Not listed San Antonio Texas 78229-3900
Not listed Madison Wisconsin 53705
Not listed Milwaukee Wisconsin 53215

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01344460, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 25, 2015 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01344460 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →