check_circleStudy Completed

Diagnostic Imaging

Bayer Identifier:

14692

ClinicalTrials.gov Identifier:

NCT00876083

EudraCT Number:

Not Available

EU CT Number:

Not Available
PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain further information on tolerability and safety in x-ray Examination

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

0 Years
  • - Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.
  • - No exclusion criteria besides the contraindications for the use of Ultravist as mentioned in the product information.

Trial summary

Enrollment Goal
44920
Trial Dates
March 2008 - September 2009
Phase
N/A
Could I Receive a placebo
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Poland
Completed
Many Locations, Indonesia
Completed
Many Locations, Korea, Republic Of
Completed
Many Locations, Taiwan
Completed
Many Locations, Thailand
Completed
Many Locations, Pakistan
Completed
Many Locations, Romania
Completed
Many Locations, Iran
Completed
Many Locations, Moldova
Completed
Many Locations, Vietnam
Completed
Many Locations, Germany
Completed
Many Locations, Italy
Completed
Many Locations, Hungary
Completed
Many Locations, Russia
Completed
Many Locations, Ukraine
Completed
Many Locations, China
Completed
Many Locations, Malaysia
Completed
Many Locations, Philippines
Completed
Many Locations, Singapore
Completed
Many Locations, Saudi Arabia
Completed
Many Locations, Bosnia And Herzegovina

Primary Outcome

  • Occurrence of adverse events
    date_rangeTime Frame:
    During and after Ultravist application on the day of examination
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • General contrast quality in the region of interest as assessed by physicians
    date_rangeTime Frame:
    On the day of examination
    enhanced_encryption
    Safety Issue:
    No

Trial design

Post-marketing surveillance Study Ultravist®-IMAGE IoproMide (UltrAvist®) to Gain further information on tolerability and safety in X-ray Examination
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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