CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 435 enrolled
Drug / intervention
Iopromide 370 mg I/mL +1 moredrug
Likely dose
Iopromide 370 mg I/mL intravenouslyAI-extracted
Key inclusion· 2
  • Age ≥18 years
  • Clinical indication for contrast-enhanced CT of head or body
Key exclusion· 2
  • Age <18 years
  • No clinical indication for contrast-enhanced CT

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00244140
NCT00244140Phase 3Completed

Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body

Bayer·interventional·Posted Oct 26, 2005·Updated Feb 28, 2014

In Brief

A Phase 3 clinical trial evaluating Iopromide 370 mg I/mL and Iopromide 300 mg I/mL for Computed Tomography and Diagnostic Imaging. Completed, enrolled 435 participants across 23 sites in 4 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesColombia, India, South Korea, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 26, 2005
Enrollment StartOct 1, 2005
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.7 years ago

Interventions

Iopromide 370 mg I/mLdrug

Iopromide (Ultravist 370 mg I/mL) administered intravenously

Iopromide 300 mg I/mLdrug

Iopromide (Ultravist 300 mg I/mL) administered intravenously