PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination

Completed

• Conditions: Diagnostic Imaging
• Interventions: Drug: Ultravist (Iopromide, BAY86-4877)

• Registration Number: NCT00876083
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use.The radiologist will administer the contrast medium to the patient as he/she would have done without the study. No other examinations will be performed than would have been done routinely.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-25
• Last Update Posted: 2011-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44920

Inclusion Criteria

• Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.

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Exclusion Criteria

• No exclusion criteria besides the contraindications for the use of Ultravist as mentioned in the product information.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Ultravist (Iopromide, BAY86-4877)	-

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events	During and after Ultravist application on the day of examination

Secondary Outcome Measures

Name	Time	Method
General contrast quality in the region of interest as assessed by physicians	On the day of examination