Phase 3
N=434
Ultravist: Safety and Efficacy in Computed Tomography of Head and Body
Computed Tomography · Diagnostic Imaging
Bottom Line
View on ClinicalTrials.gov: NCT00244140 ↗Enrolled (actual)
434
Serious AEs
0.5%
Results posted
Jul 2009
Primary outcome: Primary: The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. — 366; 17; 16; 3 Number of participants in QOI grade
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Iopromide 370 mg I/mL (Drug); Iopromide 300 mg I/mL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. |
366; 17; 16; 3; 368; 19 | — |
| SECONDARY The Ability of the Investigator to Make a Diagnosis Based on the CECT Images |
1; 0; 0; 0; 381; 20 | — |
| SECONDARY The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. |
380; 20; 2; 0 | — |
| SECONDARY The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images |
6; 2; 0; 0; 376; 18 | — |
Summary
This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician.
Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body
Eligibility Criteria
Inclusion Criteria
- Is at least 18 years old and clinically indicated for a contrast-enhanced CT of the head or body.
Exclusion Criteria
- Patients that are less than 18 years old and do not have a clinical indication for a contrast-enhanced CT of the head or body.
Data sourced from ClinicalTrials.gov (NCT00244140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.