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Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)

NCT00908310 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2014-07-17

Study results available
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Summary

This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.

Conditions

Interventions

DRUG

Omniscan

OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.

Sponsors & Collaborators

  • i3 Statprobe

    collaborator INDUSTRY

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Rubin Sheng, MD · GE Healthcare

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2013-06-30
Completion
2013-09-30

Countries

  • United States

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 NCT00908310 on ClinicalTrials.gov