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Iopromide I/mL

Phase 3

Computed Tomography | Small molecule | Other |Bayer AG|Last Updated: Feb 28, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment435

FDA Designations

No designations recorded

Clinical trial landscape

Iopromide I/mL · 1 trial · 2 indications

Phase 3 1
NCT00244140Ultravist: Safety and Efficacy in Computed Tomography of Head and BodyComputed Tomography
COMPLETED435 Analytics
PHASE3COMPLETED
Ultravist: Safety and Efficacy in Computed Tomography of Head and Body
Computed TomographyUnlock trial analytics

Study Endpoints

Primary Endpoints

The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.
post administration assessment of study images

A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.

Secondary Endpoints

The Ability of the Investigator to Make a Diagnosis Based on the CECT Images
post administration assessment of study images
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.
post administration assessment of study images
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images
post administration assessment of study images
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Iopromide 370 mg I/mLEXPERIMENTALIopromide (Ultravist 370 mg I/mL) administered intravenously
Iopromide 300 mg I/mLEXPERIMENTALIopromide (Ultravist 300 mg I/mL) administered intravenously

Interventions

NameTypeDescription
Iopromide 370 mg I/mLDRUGIopromide (Ultravist 370 mg I/mL) administered intravenously
Iopromide 300 mg I/mLDRUGIopromide (Ultravist 300 mg I/mL) administered intravenously
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

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.

Countries:United StatesColombiaIndiaSouth Korea
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Frequently asked questions about Iopromide I/mL

What is Iopromide I/mL used for?

Iopromide I/mL is a small molecule contrast agent used for Computed Tomography (CT), specifically for diagnostic imaging of the head and body. It is being developed by Bayer AG for use in CT procedures to enhance image quality.

What does Iopromide I/mL target?

Iopromide I/mL is a contrast agent that works by increasing the contrast of blood vessels and tissues during CT imaging. It contains iodine, which absorbs X-rays, allowing better visualization of anatomical structures. It does not target a specific molecular receptor.

Who makes Iopromide I/mL?

Iopromide I/mL is developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market.

What phase is Iopromide I/mL in?

Iopromide I/mL is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is not currently in active trials.

What clinical trials is Iopromide I/mL in?

Iopromide I/mL has one completed Phase 3 clinical trial, NCT00244140, titled 'Ultravist: Safety and Efficacy in Computed Tomography of Head and Body.' The trial enrolled 435 participants across the United States, Colombia, India, and South Korea.

Is Iopromide I/mL the same as Ultravist?

Yes, Iopromide I/mL is the same as Ultravist. The clinical trial NCT00244140, which studied Iopromide I/mL, is titled 'Ultravist: Safety and Efficacy in Computed Tomography of Head and Body,' confirming that Ultravist is the brand name for this drug.