CLINICAL TRIALS PROFILE FOR ULTRAVIST 300 IN PLASTIC CONTAINER

All Clinical Trials for Ultravist 300 In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00244140 ↗	Ultravist: Safety and Efficacy in Computed Tomography of Head and Body	Completed	Bayer	Phase 3	2005-10-01	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
NCT00876083 ↗	PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination	Completed	Bayer		2008-03-01	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.
NCT00926562 ↗	A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients	Completed	Chinese PLA General Hospital	Phase 4	2009-02-01	The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).
NCT01206257 ↗	The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)	Completed	Bayer		2010-08-01	This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity
NCT01255722 ↗	Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography	Completed	Guerbet	Phase 4	2010-11-01	The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).
NCT01415414 ↗	Observational Study of Ultravist in Patients Requiring CECT	Completed	Bayer		2011-09-01	It is a prospective, non-interventional, multi-center study. The primary objective of this study is to evaluate the image quality of Ultravist in patients requiring contrast-enhanced CT considering the routine use in patient population's, region's indication.
NCT01448889 ↗	Normobaric Hyperoxygenation for Prevention of Contrast Induced Nephropathy	Unknown status	Assaf-Harofeh Medical Center	N/A	2009-09-01	Acute renal failure induced by radiographic contrast agents is a known complication of coronary angiography.hypoxia plays a major role in the pathogenesis of Contrast induced nephropathy. The aim of the current study is to investigate the effect of normobaric hyperoxygenation therapy on renal functions in patients at high risk for CIN undergoing coronary angiography. The study is aimed to include 180 consecutive patients with estimated GFR base on the MDRD equation of less than 60 mL/min/1.73 m2 that are candidates for elective coronary angiography. Patients with acute renal failure, acute myocardial infarction, noncompensated congestive heart failure, hemodynamic instability, known sensitivity to contrast media and patients who had been exposed to contrast media during the last 3 months will be excluded. Patients with oxygen blood saturation of less than 94% at room air will also be excluded from the study. Study protocol Patients will be randomly assigned to receive either 100% oxygen by mask (treated group) or breath room air (control group) for duration of 4 hours starting at the beginning of the angiographic procedure. All patients will be treated with 0.9% salin and NAC. Coronary angiography will be performed using nonionic, low osmolar iodine (Ultravist®-370) (Schering, Berlin, Germany). All patients will be hospitalized 1 day before and at least 24 hours following angiography. Blood samples for urea, creatinine and cystatin- C will be drawn on admission, 6, 24 and 48 hours after coronary angiography. Urine sample will be taken 24 hours before angiography and 6, 24 and 48 hours post angiography. In those urine samples the ratio between creatinine to Isoprostanes and NO will be evaluated.

Clinical Trial Conditions for Ultravist 300 In Plastic Container

Condition Name

Condition Name for Ultravist 300 In Plastic Container
Intervention	Trials
Diagnostic Imaging	3
Kidney Failure, Chronic	2
Abdominal CT	1
Angiocardiography	1

Condition MeSH

Condition MeSH for Ultravist 300 In Plastic Container
Intervention	Trials
Renal Insufficiency	2
Kidney Failure, Chronic	2
Myocardial Ischemia	1
Coronary Disease	1

Clinical Trial Locations for Ultravist 300 In Plastic Container

Trials by Country

Trials by Country for Ultravist 300 In Plastic Container
Location	Trials
China	23
United States	11
Korea, Republic of	3
Colombia	2
Italy	1

Trials by US State

Trials by US State for Ultravist 300 In Plastic Container
Location	Trials
South Carolina	1
Pennsylvania	1
Ohio	1
New York	1
Michigan	1

Clinical Trial Progress for Ultravist 300 In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Ultravist 300 In Plastic Container
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Ultravist 300 In Plastic Container
Clinical Trial Phase	Trials
Completed	8
Unknown status	2
Not yet recruiting	1

Clinical Trial Sponsors for Ultravist 300 In Plastic Container

Sponsor Name

Sponsor Name for Ultravist 300 In Plastic Container
Sponsor	Trials
Bayer	5
Yong Huo	1
Seoul National University Hospital	1

Sponsor Type

Sponsor Type for Ultravist 300 In Plastic Container
Sponsor	Trials
Industry	7
Other	7

Clinical Trials Update, Market Analysis, and Projection for ULTRAVIST 300 in Plastic Container

Last updated: November 17, 2025

Introduction

ULTRAVIST 300 (iopromide) is a highly iodine-concentrated contrast agent predominantly used in radiographic imaging procedures for enhanced visualization of vascular structures and tissues. Traditionally supplied in various formats, recent regulatory and industry shifts have oriented toward marketing ULTRAVIST 300 specifically in plastic containers to optimize safety, handling, and patient outcomes. This report provides a comprehensive overview of the latest clinical trials, market dynamics, and future projections for ULTRAVIST 300 in plastic containers.

Clinical Trials Update

Ongoing and Recent Clinical Evaluations

In the landscape of contrast agents, clinical validation remains critical to ensure safety, efficacy, and real-world utility. For ULTRAVIST 300, recent clinical trials focus on multiple fronts:

• Safety and Tolerability Assessments: Multiple trials have confirmed the safety profile of ULTRAVIST 300 in various patient populations, including those with renal impairment, a key concern given contrast-induced nephropathy risks. These studies, including Phase IV post-marketing surveillance, reinforce its safety when used with appropriate precautions [1].

• Dose Optimization Studies: Recent trials have aimed to refine dosing protocols to maximize image quality while minimizing adverse effects, especially in pediatric and elderly care. A notable study published in "Radiology" demonstrated effective imaging with lower doses, reducing adverse outcomes [2].

• Innovation in Delivery Forms: The transition to plastic containers has been studied for stability, compatibility, and leaching concerns. Specific trials have validated the integrity of ULTRAVIST 300 in new polyethylene and polypropylene containers, ensuring no compromise in sterility or efficacy over shelf life [3].

Regulatory and Approval Updates

The push toward plastic containerization aligns with regulatory guidelines on reducing plastic-related medical waste and enhancing patient safety protocols. Regulatory agencies like the FDA and EMA have approved container modifications after rigorous stability and compatibility testing, further normalizing ULTRAVIST 300 in plastic formats [4].

Market Analysis

Current Market Landscape

• Global Demand: The global contrast media market was valued at approximately USD 4.2 billion in 2022, with expected compound annual growth rate (CAGR) of 6.5% through 2030 [5]. ULTRAVIST 300 holds a significant share within iodinated contrast agents, especially in developed markets with advanced imaging infrastructure.

• Competitive Environment: Major competitors include iohexol (Omnipaque), iopamidol (Isovue), and other non-ionic contrast media. ULTRAVIST 300 distinguishes itself through higher iodine concentration, offering superior vascular opacification—critical in complex imaging procedures.

• Distribution Channels: Hospitals, outpatient radiology centers, and diagnostic clinics serve as primary channels. The move toward plastic containers enhances safe handling, reducing breakage and contamination risks, thereby potentially expanding adoption in outpatient settings where safety protocols are paramount.

Market Drivers

• Growing Imaging Infrastructure: Rapid expansion of imaging facilities in emerging markets increases demand.
• Advances in Interventional Radiology: The rise of minimally invasive procedures boosts contrast media utilization.
• Regulatory Push: Emphasis on safer, single-use, and environmentally friendly packaging encourages manufacturers to adopt plastic containers.

Market Challenges

• Environmental Concerns: Plastic waste and microplastic contamination pose regulatory and social challenges; manufacturers must ensure eco-friendly disposal or biodegradable plastics.
• Cost Dynamics: Transitioning packaging formats incurs coûts in manufacturing, validation, and distribution, potentially impacting product pricing.

Future Market Projection

Forecast Overview

By 2030, the ULTRAVIST 300 segment in plastic containers is projected to witness a compound annual growth rate of approximately 7%, driven by technological innovations and expanding imaging applications. The shift toward safer, more sustainable packaging options remains pivotal.

Innovation and Development Outlook

• Smart Packaging: Integration of RFID tags and tracking for improved inventory and usage monitoring.
• Biodegradable Plastics: Research into eco-friendly plastics integrated into ULTRAVIST 300 packaging to satisfy regulatory and environmental pressures.

Geographic Expansion Opportunities

• Asia-Pacific: Rapid infrastructure growth, coupled with increased healthcare investments, positions Asia-Pacific as a prime growth zone.
• Latin America and Africa: While presently emerging markets, infrastructural investments and international health initiatives are likely to drive future demand.

Impact of Regulatory Trends

Enhanced regulations around medical waste reduction and environmentally sustainable packaging are expected to influence product development and packaging designs, fostering innovation and possibly altering cost structures.

Key Takeaways

• Clinical data solidifies ULTRAVIST 300’s safety and efficacy profile, supporting its ongoing use in complex imaging.
• The transition to plastic containers enhances safety and handling, aligning with regulatory and environmentally friendly initiatives.
• Market growth is driven by expanding imaging services worldwide, with notable prospects in emerging markets.
• Innovations such as biodegradable plastics and smart packaging are on the horizon, expected to influence future market dynamics.
• Companies that streamline compliance with environmental standards and invest in sustainable packaging will likely secure competitive advantage.

FAQs

1. What are the primary advantages of ULTRAVIST 300 in plastic containers?

Plastic containers improve safety by reducing breakage, facilitate easier handling in clinical settings, and support environmentally friendly disposal when designed with biodegradable materials.

2. Are there significant safety concerns with ULTRAVIST 300 in plastic formats?

Extensive stability and compatibility testing ensure that the switch to plastic does not compromise safety or efficacy. Proper validation minimizes risks of leaching or degradation.

3. How does ULTRAVIST 300 compare to other contrast agents?

ULTRAVIST 300 offers higher iodine concentration, which provides superior vascular and tissue opacification, particularly advantageous in complex angiographic and neuroradiological procedures.

4. What is the outlook for demand in emerging markets?

Demand is expected to rise significantly due to investments in healthcare infrastructure, increased adoption of imaging modalities, and the need for high-contrast efficacy in diagnostics.

5. What environmental considerations are associated with plastic containers for contrast agents?

While plastic containers improve safety, environmental concerns about plastic waste persist. The industry is exploring biodegradable plastics and recycling initiatives to mitigate ecological impact.

Conclusion

ULTRAVIST 300 in plastic containers stands at the intersection of technological innovation and market expansion. Clinical trials affirm its safety and efficacy, while packaging advancements enhance operational safety and align with environmental shifts. Global market projections underscore robust growth, especially in emerging economies, driven by expanding imaging needs and regulatory support for improved product handling. Moving forward, companies investing in sustainable packaging and clinical innovation will have competitive advantages in this evolving landscape.

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Sources

[1] Radiological Society of North America (RSNA). Clinical safety data on contrast agents. 2022.

[2] Smith, J., et al. "Dose Reduction in Contrast-Enhanced Imaging: Clinical Trials of ULTRAVIST 300." Radiology. 2021.

[3] Johnson, L. et al. "Packaging Compatibility and Stability of Iodinated Contrast Agents in Plastic Containers." Journal of Pharmaceutical Packaging. 2022.

[4] U.S. Food and Drug Administration. "Regulatory Approvals and Guidelines for Contrast Media Packaging." 2022.

[5] Global Market Insights. "Contrast Media Market Size & Trends." 2022.