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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00876083
First Posted: April 6, 2009
Last Update Posted: February 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  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 ]

Secondary Outcome Measures:
  • General contrast quality in the region of interest as assessed by physicians [ Time Frame: On the day of examination ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876083


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

Additional Information:
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
First Submitted: April 3, 2009
First Posted: April 6, 2009
Last Update Posted: February 28, 2011
Last Verified: February 2011

Keywords provided by Bayer:
Drug utilization review