CLINICAL TRIALS PROFILE FOR IOPAMIDOL-370 IN PLASTIC CONTAINER

All Clinical Trials for Iopamidol-370 In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX-CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Averion International Corporation	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Clinical Trial Conditions for Iopamidol-370 In Plastic Container

Condition Name

Condition Name for Iopamidol-370 In Plastic Container
Intervention	Trials
Coronary Artery Stenosis	3
Coronary Artery Disease	2
Diabetes Mellitus	2

Condition MeSH

Condition MeSH for Iopamidol-370 In Plastic Container
Intervention	Trials
Renal Insufficiency	6
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3

Clinical Trial Locations for Iopamidol-370 In Plastic Container

Trials by Country

Trials by Country for Iopamidol-370 In Plastic Container
Location	Trials
United States	20
Italy	2
China	2
Canada	2
United Kingdom	1

Trials by US State

Trials by US State for Iopamidol-370 In Plastic Container
Location	Trials
New Jersey	10
California	2
North Carolina	2
Illinois	2
Texas	1

Clinical Trial Progress for Iopamidol-370 In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Iopamidol-370 In Plastic Container
Clinical Trial Phase	Trials
Phase 4	16
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Iopamidol-370 In Plastic Container
Clinical Trial Phase	Trials
Completed	15
Recruiting	5
Terminated	5

Clinical Trial Sponsors for Iopamidol-370 In Plastic Container

Sponsor Name

Sponsor Name for Iopamidol-370 In Plastic Container
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

Sponsor Type for Iopamidol-370 In Plastic Container
Sponsor	Trials
Industry	27
Other	22
NIH	2

Iopamidol-370: Clinical Trials, Market Analysis, and Projections

Introduction

Iopamidol, a non-ionic radiopaque contrast medium, is widely used in various medical imaging procedures. This article focuses on Iopamidol-370, specifically its clinical trials, market analysis, and future projections.

Clinical Trials and Usage

Indications and Administration

Iopamidol-370 is indicated for several intravascular procedures, including coronary arteriography, left ventriculography, and intravenous contrast enhancement in computed tomography (CT) of the body in adults. It is also used for peripheral arteriography, cerebral arteriography, and excretory urography[4,.

Pharmacokinetics

Clinical studies have shown that iopamidol is immediately diluted in the circulating plasma after intravascular injection. It is distributed between the circulating blood volume and other extracellular fluid compartments, with no significant deposition in tissues. The elimination half-life is approximately two hours, and it is excreted mainly by glomerular filtration without significant metabolism or biotransformation[4,.

Safety and Side Effects

While generally safe, iopamidol can cause various side effects. Common adverse reactions include changes in vital signs and hemodynamic parameters, as well as more severe but rare reactions such as heart attack, stroke, and blood clotting problems. Other potential side effects include skin reactions, changes in consciousness, and in severe cases, seizures or loss of consciousness[5,.

Clinical Studies Outcomes

Clinical studies involving iopamidol have demonstrated its efficacy in enhancing diagnostic precision in various imaging procedures. For instance, it has been shown to refine diagnostic accuracy in areas of the brain and to investigate the presence and extent of certain malignancies. The incidence of adverse reactions is relatively low, with most reactions being mild and transient[1][4].

Market Analysis

Current Market Size and Growth

The global iopamidol API market, which includes Iopamidol-370, was valued at US$ 245 million in 2023. This market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.4% from 2024 to 2030, reaching a projected value of US$ 326.3 million by 2030[2].

Key Players

The main players in the iopamidol API market include Bracco Imaging and Stellite. These companies are significant contributors to the production and distribution of iopamidol, including the Iopamidol-370 formulation[2].

Market Segmentation

The market is segmented by type, application, production region, and consumption region. The increasing demand for advanced diagnostic imaging procedures, particularly in cardiovascular and neurological applications, drives the growth of the iopamidol market[2].

Market Projections

Future Demand

The demand for iopamidol is expected to rise due to the increasing prevalence of cardiovascular diseases and the need for precise diagnostic imaging. The growing aging population and advancements in medical imaging technologies are also contributing factors to the market's growth[2].

Technological Advancements

Advancements in imaging technologies, such as dynamic computed tomographic imaging, are enhancing the utility of iopamidol. These technologies allow for greater contrast enhancement and better visualization of internal structures, further solidifying the position of iopamidol in the diagnostic market[1].

Regulatory Considerations

Regulatory approvals and guidelines play a crucial role in the market dynamics of iopamidol. Ensuring compliance with FDA regulations and other international standards is essential for the continued growth and acceptance of iopamidol-based products[1][3].

Key Takeaways

• Clinical Efficacy: Iopamidol-370 is effective in various intravascular procedures and CT imaging, with a favorable safety profile.
• Market Growth: The global iopamidol API market is projected to grow at a CAGR of 4.4% from 2024 to 2030.
• Key Players: Bracco Imaging and Stellite are major players in the iopamidol API market.
• Future Demand: Increasing demand for diagnostic imaging, particularly in cardiovascular and neurological applications, will drive market growth.
• Technological Advancements: Advances in imaging technologies will enhance the utility and demand for iopamidol.

FAQs

What is Iopamidol-370 used for?

Iopamidol-370 is used for various intravascular procedures, including coronary arteriography, left ventriculography, and intravenous contrast enhancement in computed tomography (CT) of the body[4].

What are the common side effects of Iopamidol-370?

Common side effects include changes in vital signs and hemodynamic parameters. More severe but rare reactions can include heart attack, stroke, and blood clotting problems[5].

Who are the main players in the iopamidol API market?

The main players in the iopamidol API market include Bracco Imaging and Stellite[2].

What is the projected market size of the iopamidol API market by 2030?

The global iopamidol API market is expected to reach US$ 326.3 million by 2030[2].

How is Iopamidol-370 administered?

Iopamidol-370 is administered intravascularly, using an automated contrast injection system or a contrast media transfer set approved for use with this contrast agent[3].

Sources

1. ISOVUE® (Iopamidol Injection) - FDA Label. accessdata.fda.gov.
2. Global Iopamidol API Market Research Report 2024. valuates.com.
3. ISOVUE® Imaging Bulk Package - DailyMed. dailymed.nlm.nih.gov.
4. IsovueTM Iopamidol Injection USP. e-lactancia.org.
5. Iopamidol (injection route) - Mayo Clinic. mayoclinic.org.