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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00876083
First received: April 3, 2009
Last updated: February 25, 2011
Last verified: February 2011
  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.


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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876083

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

Additional Information:
No publications provided

Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on April 15, 2014