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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: April 3, 2009
Last updated: February 25, 2011
Last verified: February 2011
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.

Condition Intervention
Diagnostic Imaging
Drug: Ultravist (Iopromide, BAY86-4877)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Surveillance Study Ultravist®-IMAGE IoproMide (UltrAvist®) to Gain Further Information on Tolerability and Safety in X-ray Examination

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: During and after Ultravist application on the day of examination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • General contrast quality in the region of interest as assessed by physicians [ Time Frame: On the day of examination ] [ Designated as safety issue: No ]

Enrollment: 44920
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Ultravist (Iopromide, BAY86-4877)
Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of female and male patients who require an X-ray examination with contrast enhancement. Physicians should consult the full prescribing information for Ultravist before enrolling patients and familiarize themselves with the safety information in the product package label.

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria besides the contraindications for the use of Ultravist as mentioned in the product information.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00876083

  Show 21 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG Identifier: NCT00876083     History of Changes
Other Study ID Numbers: 14692  UV0701  13422  13421  14480  13276  14336  14181  13602  14243  13275  14180  14338  13859  14376  14337  14245  13212  14526  14527  14528  14586  14661 
Study First Received: April 3, 2009
Last Updated: February 25, 2011
Health Authority: Bosnia and Herzegovina: Food and Drug Administrtion
China: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Indonesia: National Agency of Drug and Food Control
Iran: Ethics Committee
Italy: Ethics Committee
South Korea: Korea Food and Drug Administration (KFDA)
Moldova: National Ethics Committee
Malaysia: Medical Research Ethics Committee (MREC)
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drugs
Philippines: Department of Health
Pakistan: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Natioanl Ethics Committee
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Thailand: Ethical Committee
Taiwan: Institutional Review Board
Ukraine: Central Ethical Comission
Vietnam: Central Ethical Comission

Keywords provided by Bayer:
Drug utilization review processed this record on January 18, 2017