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

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.
 
ClinicalTrials.gov Identifier: NCT00876083
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : February 28, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Diagnostic Imaging Drug: Ultravist (Iopromide, BAY86-4877)

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Study Type : Observational
Actual Enrollment : 44920 participants
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
Study Start Date : March 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: During and after Ultravist application on the day of examination ]

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


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.


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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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


Locations
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Bosnia and Herzegovina
Many Locations, Bosnia and Herzegovina
China
Many Locations, China
Germany
Many Locations, Germany
Hungary
Many Locations, Hungary
Indonesia
Many Locations, Indonesia
Iran, Islamic Republic of
Many Locations, Iran, Islamic Republic of
Italy
Many Locations, Italy
Korea, Republic of
Many Locations, Korea, Republic of
Malaysia
Many Locations, Malaysia
Moldova, Republic of
Many Locations, Moldova, Republic of
Pakistan
Many Locations, Pakistan
Philippines
Many Locations, Philippines
Poland
Many Locations, Poland
Romania
Many Locations, Romania
Russian Federation
Many Locations, Russian Federation
Saudi Arabia
Many Locations, Saudi Arabia
Singapore
Many Locations, Singapore
Taiwan
Many Locations, Taiwan
Thailand
Many Locations, Thailand
Ukraine
Many Locations, Ukraine
Vietnam
Many Locations, Vietnam
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00876083    
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 Posted: April 6, 2009    Key Record Dates
Last Update Posted: February 28, 2011
Last Verified: February 2011
Keywords provided by Bayer:
Drug utilization review