CLINICAL TRIALS PROFILE FOR ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

All Clinical Trials for Esmolol Hydrochloride 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.
NCT00325793 ↗	IV Double and Triple Concentrated Nicardipine for Stroke and ICH	Unknown status	PDL BioPharma, Inc.	Phase 4	2004-01-01	Hypertension (high blood pressure) can often cause neurological worsening in patients with stroke, intracerebral hemorrhage and subarachnoid hemorrhage. Intravenous infusion of nicardipine (Cardene) for control of hypertension is FDA approved. The disadvantage of Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). The purpose of this study is to evaluate safety and efficacy of double or triple concentrated peripheral intravenous (IV) Nicardipine.
NCT00325793 ↗	IV Double and Triple Concentrated Nicardipine for Stroke and ICH	Unknown status	OSF Healthcare System	Phase 4	2004-01-01	Hypertension (high blood pressure) can often cause neurological worsening in patients with stroke, intracerebral hemorrhage and subarachnoid hemorrhage. Intravenous infusion of nicardipine (Cardene) for control of hypertension is FDA approved. The disadvantage of Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). The purpose of this study is to evaluate safety and efficacy of double or triple concentrated peripheral intravenous (IV) Nicardipine.
NCT00713401 ↗	Safety Study of Tecadenoson to Treat Atrial Fibrillation	Completed	Gilead Sciences	Phase 2	2008-02-01	Assess the tolerability and safety of a rapid bolus of tecadenoson at different dose levels when given alone and in combination with a beta-blocker (esmolol) in patients with atrial fibrillation to control rapid heart rate. Explore the pharmacokinetic and pharmacodynamic effects when given alone and in combination with beta-blocker (esmolol).

Clinical Trial Conditions for Esmolol Hydrochloride In Plastic Container

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Esmolol Hydrochloride In Plastic Container

Trials by Country

Trials by Country for Esmolol Hydrochloride 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 In Plastic Container
Location	Trials
California	6
Illinois	5
Utah	2
North Carolina	2
New York	2

Clinical Trial Progress for Esmolol Hydrochloride In Plastic Container

Clinical Trial Phase

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

Clinical Trial Sponsors for Esmolol Hydrochloride In Plastic Container

Sponsor Name

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

Sponsor Type

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

Esmolol Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Esmolol hydrochloride, a beta-adrenergic blocker, has been a staple in cardiovascular medicine since its approval in 1986. Recently, it has garnered attention for its potential in treating diabetic foot ulcers (DFUs) when administered topically. Here, we delve into the latest clinical trials, market analysis, and projections for esmolol hydrochloride.

Clinical Trials Update

Topical Esmolol for Diabetic Foot Ulcers

A significant development in the clinical use of esmolol hydrochloride is its application in treating DFUs. A phase 3 randomized, double-blind, multicenter clinical trial conducted in India from December 2018 to August 2020 has shown promising results.

• Participants and Design: The trial involved 176 adults with DFUs, randomized into three groups: esmolol 14% gel with standard of care (SoC), SoC only, and vehicle with SoC. The treatment phase lasted 12 weeks, followed by a 12-week follow-up period[1][5].
• Outcomes: The primary outcome was the proportion of wound closure within the 12-week treatment phase. The results indicated that 60.3% of participants in the esmolol with SoC group achieved target ulcer closure within 12 weeks, compared to 41.7% in the SoC only group. By the end of the study (week 24), 77.2% of the esmolol with SoC group and 55.6% of the SoC only group had achieved target ulcer closure[1][5].
• Safety: The trial reported that 18.8% of participants experienced treatment-emergent adverse events, but most of these were not attributed to the study drug[1].

This study marks a significant milestone, as it is the first randomized, double-blind clinical trial to establish the efficacy and safety of topical esmolol for healing noninfected DFUs.

Market Analysis

Global Market Size and Growth

The global esmolol hydrochloride market is expected to experience steady growth driven by several factors.

• Market Size: The global esmolol hydrochloride market size is projected to be USD XX million in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 4.0% from 2024 to 2031[2].
• Regional Growth: North America currently dominates the market, with significant growth anticipated due to rising cardiovascular disease rates, increased surgical procedures, and greater awareness of effective treatment options. The Asia-Pacific region is also expected to see substantial growth, driven by increasing cardiovascular disease rates, rising surgical interventions, and improving healthcare access[2].

Market Segmentation

• Clinical Settings: Clinics are increasingly adopting esmolol hydrochloride for outpatient procedures and cardiac management, contributing to the market's growth. The demand is heightened by the need for effective treatment alternatives in non-hospital settings[2].
• Geographical Distribution: The Asia-Pacific region holds around 23% of the global revenue and is expected to grow at a CAGR of 6.0% from 2024 to 2031. Latin America and the Middle East and Africa also show potential, with CAGRs of 3.4% and 3.7%, respectively[2].

Projections and Future Outlook

Market Expansion

The esmolol hydrochloride market is poised for expansion due to several key factors:

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of cardiovascular diseases globally is expected to boost sales, particularly in regions with established healthcare infrastructures[2].
• Emerging Markets: The Asia-Pacific and Latin American markets are expected to contribute significantly to the growth, driven by growing healthcare access and increasing awareness of treatment options[2].

Clinical and Therapeutic Expansion

• Topical Applications: The success of topical esmolol in treating DFUs opens new therapeutic avenues. This could lead to increased adoption and expansion into other wound care applications[1][5].
• Ongoing Clinical Trials: With over 100 clinical trials listed, including phase 3 and phase 4 trials, there is ongoing research into various applications of esmolol hydrochloride, which could further expand its market[3].

Key Takeaways

• Clinical Efficacy: Topical esmolol hydrochloride has shown significant efficacy in healing noninfected DFUs, offering a new treatment modality.
• Market Growth: The global esmolol hydrochloride market is expected to grow at a CAGR of 4.0% from 2024 to 2031, driven by increasing cardiovascular disease rates and expanding healthcare access.
• Regional Opportunities: North America and the Asia-Pacific region are key markets, with significant growth potential due to their healthcare infrastructure and rising disease prevalence.
• Therapeutic Expansion: The success in DFU treatment could pave the way for other wound care applications, further expanding the market.

FAQs

What is the primary outcome of the phase 3 clinical trial for topical esmolol in treating DFUs?

The primary outcome was the proportion of wound closure within the 12-week treatment phase, with 60.3% of participants in the esmolol with SoC group achieving target ulcer closure compared to 41.7% in the SoC only group[1][5].

What is the projected CAGR for the global esmolol hydrochloride market from 2024 to 2031?

The global esmolol hydrochloride market is expected to grow at a CAGR of 4.0% from 2024 to 2031[2].

Which regions are expected to contribute significantly to the growth of the esmolol hydrochloride market?

North America and the Asia-Pacific region are expected to be key contributors, driven by rising cardiovascular disease rates and improving healthcare access[2].

What are the potential new therapeutic applications of esmolol hydrochloride?

The success in treating DFUs could lead to its use in other wound care applications, expanding its therapeutic scope[1][5].

How many clinical trials are currently listed for esmolol hydrochloride?

There are over 100 clinical trials listed, including phase 3 and phase 4 trials, indicating ongoing research into various applications of esmolol hydrochloride[3].

Sources

1. JAMA Network Open: "Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomized Clinical Trial"[1].
2. Cognitive Market Research: "Global Esmolol Hydrochloride Market Report 2024"[2].
3. DrugPatentWatch: "ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER"[3].
4. PubChem: "Esmolol Hydrochloride | C16H26ClNO4 | CID 104769"[4].
5. PubMed: "Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomized Clinical Trial"[5].

Last updated: 2025-01-05