CLINICAL TRIALS PROFILE FOR ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER

All Clinical Trials for Esmolol Hydrochloride Double Strength In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	National Health and Medical Research Council, Australia	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	The George Institute	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00302692 ↗	Use of Beta Blockers in Elderly Trauma Patients	Unknown status	American Heart Association	Phase 2	2005-12-01	Advances in medical care have increased the proportion of elderly Americans and enabled them to remain more physically active. This has resulted in an unprecedented increase in the number of geriatric patients admitted to trauma centers. The elderly constitute 23% of trauma center admissions, but 36% of all trauma deaths. This disproportionately high mortality is attributable to a higher prevalence of pre-existing conditions, particularly, cardiac disease. Multi-system injuries result in critical cardiac stress. Although beta-blockade has been shown to decrease morbidity and mortality in patients at risk for myocardial infarction after elective surgery, their use in trauma patients with potential underlying cardiac disease has not been previously studied. We hypothesize that routine administration of beta-blockers after resuscitation will reduce morbidity and mortality in elderly trauma patients with, or at risk for, underlying cardiac disease. This study is a randomized, prospective clinical trial. One cohort will receive routine trauma intensive care, and the other, the same care plus beta-blockade after completion of resuscitation. The primary outcome will be mortality. Secondary outcomes include MI, length of stay, organ dysfunction, cardiac, and other complications. Changes in outcome may not be due to reduction in myocardial oxygen demand and heart rate. Laboratory studies demonstrate that circulating inflammatory cytokines contribute to cardiac risk in trauma patients, and their production is influenced by adrenergic stimulation. We will measure circulating IL-6, TNF alpha, IL-1beta, and measure NF-kB and p38 MAP kinase activation in peripheral blood leukocytes, and determine the effect of beta-blockade on the production of these inflammatory markers. Finally, the wide variation in patient response to beta-blockers is attributed to genetic variability in the adrenergic receptor. Therefore, we will identify single nucleotide polymorphisms (SNPS) within the beta-adrenergic receptor, and determine their effects on mortality and response to beta-blockade. This study will provide the first randomized, prospective trial designed to reduce morbidity and mortality in elderly trauma patients at risk for cardiac disease. The laboratory and genetic component will provide additional insights that may explain treatment effects, lead to new therapeutic strategies, and have the potential to lead to additional areas of investigation.
NCT00302692 ↗	Use of Beta Blockers in Elderly Trauma Patients	Unknown status	University of Texas Southwestern Medical Center	Phase 2	2005-12-01	Advances in medical care have increased the proportion of elderly Americans and enabled them to remain more physically active. This has resulted in an unprecedented increase in the number of geriatric patients admitted to trauma centers. The elderly constitute 23% of trauma center admissions, but 36% of all trauma deaths. This disproportionately high mortality is attributable to a higher prevalence of pre-existing conditions, particularly, cardiac disease. Multi-system injuries result in critical cardiac stress. Although beta-blockade has been shown to decrease morbidity and mortality in patients at risk for myocardial infarction after elective surgery, their use in trauma patients with potential underlying cardiac disease has not been previously studied. We hypothesize that routine administration of beta-blockers after resuscitation will reduce morbidity and mortality in elderly trauma patients with, or at risk for, underlying cardiac disease. This study is a randomized, prospective clinical trial. One cohort will receive routine trauma intensive care, and the other, the same care plus beta-blockade after completion of resuscitation. The primary outcome will be mortality. Secondary outcomes include MI, length of stay, organ dysfunction, cardiac, and other complications. Changes in outcome may not be due to reduction in myocardial oxygen demand and heart rate. Laboratory studies demonstrate that circulating inflammatory cytokines contribute to cardiac risk in trauma patients, and their production is influenced by adrenergic stimulation. We will measure circulating IL-6, TNF alpha, IL-1beta, and measure NF-kB and p38 MAP kinase activation in peripheral blood leukocytes, and determine the effect of beta-blockade on the production of these inflammatory markers. Finally, the wide variation in patient response to beta-blockers is attributed to genetic variability in the adrenergic receptor. Therefore, we will identify single nucleotide polymorphisms (SNPS) within the beta-adrenergic receptor, and determine their effects on mortality and response to beta-blockade. This study will provide the first randomized, prospective trial designed to reduce morbidity and mortality in elderly trauma patients at risk for cardiac disease. The laboratory and genetic component will provide additional insights that may explain treatment effects, lead to new therapeutic strategies, and have the potential to lead to additional areas of investigation.

Clinical Trial Conditions for Esmolol Hydrochloride Double Strength In Plastic Container

Condition Name

Condition Name for Esmolol Hydrochloride Double Strength In Plastic Container
Intervention	Trials
Septic Shock	9
Hypertension	6
Postoperative Pain	6
Tachycardia	5

Condition MeSH

Condition MeSH for Esmolol Hydrochloride Double Strength In Plastic Container
Intervention	Trials
Shock	12
Shock, Septic	11
Pain, Postoperative	9
Tachycardia	6

Clinical Trial Locations for Esmolol Hydrochloride Double Strength In Plastic Container

Trials by Country

Trials by Country for Esmolol Hydrochloride Double Strength In Plastic Container
Location	Trials
United States	28
China	18
Egypt	15
Brazil	10
France	7

Trials by US State

Trials by US State for Esmolol Hydrochloride Double Strength In Plastic Container
Location	Trials
California	6
Illinois	5
Utah	2
North Carolina	2
New York	2

Clinical Trial Progress for Esmolol Hydrochloride Double Strength In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Esmolol Hydrochloride Double Strength In Plastic Container
Clinical Trial Phase	Trials
Phase 4	36
Phase 3	13
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Esmolol Hydrochloride Double Strength In Plastic Container
Clinical Trial Phase	Trials
Completed	44
Unknown status	25
Recruiting	18

Clinical Trial Sponsors for Esmolol Hydrochloride Double Strength In Plastic Container

Sponsor Name

Sponsor Name for Esmolol Hydrochloride Double Strength In Plastic Container
Sponsor	Trials
Baxter Healthcare Corporation	4
The University of Hong Kong	4
Ain Shams University	4

Sponsor Type

Sponsor Type for Esmolol Hydrochloride Double Strength In Plastic Container
Sponsor	Trials
Other	134
Industry	15

Esmolol Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Esmolol Hydrochloride

Esmolol hydrochloride is a short-acting beta-blocker widely used in managing various cardiovascular conditions, including supraventricular tachycardia, noncompensatory sinus tachycardia, and perioperative hypertension. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Topical Esmolol for Diabetic Foot Ulcers (DFUs)

A significant recent development involves the use of topical esmolol hydrochloride for the treatment of diabetic foot ulcers (DFUs). A randomized, double-blind, multicenter clinical trial conducted from December 2018 to August 2020 evaluated the efficacy of topical esmolol in healing uninfected DFUs.

• Study Design and Participants: The trial involved 176 participants with DFUs, randomized into three groups: esmolol 14% gel plus standard of care (SoC), SoC only, and vehicle plus SoC. The treatment phase lasted 12 weeks, followed by a 12-week follow-up period[1][5].
• Outcomes: The study found that significantly more participants in the esmolol with SoC group achieved wound closure within the 12-week treatment period compared to those receiving SoC only. The rate of DFU closure within 24 weeks was also higher in the esmolol with SoC group[1][5].

Safety and Adverse Events

The trial reported 63 treatment-emergent adverse events among 33 participants, with 12 events considered serious. However, none of the serious adverse events were deemed drug-related by the investigators. Most adverse events were not associated with the study drug[1].

Market Analysis

Global Market Size and Growth Rate

The global esmolol hydrochloride market is projected to expand at a compound annual growth rate (CAGR) of 3.5% to 4.8% from 2024 to 2030/2031. By 2030, the market size is expected to reach approximately $487.2 million[2][4].

Regional Market Dynamics

• North America: Currently dominates the market, driven by the increasing incidence of heart diseases and well-established healthcare infrastructure. The region is expected to grow at a CAGR of 2.2% from 2024 to 2031[2][4].
• Asia-Pacific: Anticipated to witness substantial growth, driven by rising healthcare expenditure, growing awareness of cardiovascular health, and an increase in lifestyle-related health issues. This region is expected to grow at a CAGR of 6.0% from 2024 to 2031[2][4].
• Europe: Expected to grow at a CAGR of 2.5% from 2024 to 2031, fueled by advancements in critical care and anesthesiology, as well as an increasing geriatric population[2][4].
• Latin America and Middle East & Africa: These regions are also growing, albeit at a slower pace, with Latin America expected to grow at a CAGR of 3.4% and the Middle East & Africa at a CAGR of 3.7% from 2024 to 2031[2][4].

Key Drivers of Market Growth

• Rising Prevalence of Cardiovascular Diseases: The increasing global incidence of cardiovascular diseases is a major driver of the esmolol hydrochloride market[2][4].
• Growing Number of Surgical Procedures: The rise in surgical procedures, particularly in perioperative settings, is boosting demand for esmolol hydrochloride due to its rapid onset and short half-life[2][4].
• Advancements in Healthcare Infrastructure: Heightened investments in healthcare infrastructure, especially in emerging economies, are enhancing access to advanced treatment options, including esmolol hydrochloride[2][4].
• Regulatory Approvals and Expanded Indications: Regulatory approvals for expanded indications have significantly contributed to market growth, with esmolol now approved for broader applications such as perioperative hypertension and arrhythmia management[2][4].

Competitive Landscape

The esmolol hydrochloride market is highly competitive, with key players including Pfizer Inc., Novartis AG, Teva Pharmaceutical Industries Ltd., Mylan N.V., and Aurobindo Pharma Ltd. These companies are adopting strategies like mergers and acquisitions, product launches, and geographical expansion to strengthen their market presence[2].

End-Use Segmentation

• Hospitals: Hospitals are the largest consumers of esmolol hydrochloride, using the drug extensively for managing tachycardia and high blood pressure during surgeries[2][4].
• Clinics and Research Institutes: These also play a significant role, particularly in the development and testing of new formulations and applications of esmolol hydrochloride[2][4].

Financial Trajectory

The financial trajectory of the esmolol hydrochloride market is positive, with steady growth anticipated over the forecast period. Here are some key financial highlights:

• Global Market Size: Expected to reach $487.2 million by 2030[2][4].
• CAGR: Ranging from 3.5% to 4.8% from 2024 to 2030/2031[2][4].

Challenges and Opportunities

Generic Competition

The market faces competition from generic formulations, which can impact the pricing and market share of branded products. However, innovations in formulations and delivery systems, as well as collaborations with research institutions, are driving market expansion[2].

Expanding Indications

The recent clinical trials on topical esmolol for DFUs open up new avenues for the drug's application, potentially expanding its market beyond traditional cardiovascular uses.

"Esmolol hydrochloride is a fast and short-acting cardioselective β1-blocker intended for parenteral use. Its primary applications are in the fields of diagnostics and emergency medicine."[3]

Key Takeaways

• Clinical Trials: Topical esmolol hydrochloride has shown significant efficacy in healing diabetic foot ulcers, offering a new treatment modality.
• Market Growth: The global esmolol hydrochloride market is expected to grow at a CAGR of 3.5% to 4.8% from 2024 to 2030/2031.
• Regional Dynamics: North America, Asia-Pacific, and Europe are key regions driving market growth.
• Drivers: Rising cardiovascular diseases, growing surgical procedures, and advancements in healthcare infrastructure are major drivers.
• Competitive Landscape: The market is highly competitive with key players focusing on innovations and geographical expansion.

FAQs

What are the primary uses of esmolol hydrochloride?

Esmolol hydrochloride is primarily used for the short-term treatment of supraventricular tachycardia, rapid control of ventricular rate in atrial fibrillation or flutter, and managing tachycardia and hypertension during the perioperative phase[3].

What is the projected market size of esmolol hydrochloride by 2030?

The global esmolol hydrochloride market is expected to reach approximately $487.2 million by 2030[2][4].

Which regions are driving the growth of the esmolol hydrochloride market?

North America, Asia-Pacific, and Europe are the key regions driving the growth of the esmolol hydrochloride market, with Asia-Pacific expected to witness the highest growth rate[2][4].

What are the main drivers of the esmolol hydrochloride market?

The main drivers include the rising prevalence of cardiovascular diseases, growing number of surgical procedures, advancements in healthcare infrastructure, and regulatory approvals for expanded indications[2][4].

What is the significance of the recent clinical trial on topical esmolol for diabetic foot ulcers?

The recent clinical trial demonstrated that topical esmolol hydrochloride significantly improves the healing of diabetic foot ulcers, offering a novel treatment modality for this condition[1][5].

Sources

1. JAMA Network Open: "Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Randomized Clinical Trial"[1].
2. Drug Patent Watch: "Esmolol Hydrochloride Market Dynamics and Financial Trajectory"[2].
3. Public Assessment Report - CBG-Meb: "Esmolol Hydrochloride"[3].
4. Cognitive Market Research: "Esmolol Hydrochloride Market Report 2024 (Global Edition)"[4].
5. PubMed: "Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Randomized, Double-Blind, Multicenter, Phase 3 Clinical Trial"[5].