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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR LEVOPHED


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All Clinical Trials for Levophed

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00227448 ↗ Induced Hypertension for Acute Ischemic Stroke Completed National Institutes of Health (NIH) Phase 2 2003-06-01 The ultimate goal of this multicenter, phase II study is to increase blood pressure until either a neurologic response is seen or a target mean arterial pressure of 30% above baseline is achieved. IV fluids, IV phenylephrine and/or IV norepinephrine are used to rapidly raise mean arterial pressure in a controlled manner as serial assessments of neurologic function are performed.
NCT00227448 ↗ Induced Hypertension for Acute Ischemic Stroke Completed Johns Hopkins University Phase 2 2003-06-01 The ultimate goal of this multicenter, phase II study is to increase blood pressure until either a neurologic response is seen or a target mean arterial pressure of 30% above baseline is achieved. IV fluids, IV phenylephrine and/or IV norepinephrine are used to rapidly raise mean arterial pressure in a controlled manner as serial assessments of neurologic function are performed.
NCT02118467 ↗ Vasoactive Drugs in Intensive Care Unit Recruiting University of Chicago Phase 4 2014-05-01 The investigators hypothesis is that for ICU patients with shock, the use of the vasoactive drugs phenylephrine and vasopressin will reduce tachydysrhythmias when compared to norepinephrine and epinephrine. To investigate this hypothesis, the investigators are conducting a randomized double blind controlled trial comparing phenylephrine and vasopressin vs. norepinephrine and epinephrine in ICU patients with shock that is not responsive to IV fluids. All patients admitted to the adult intensive care units at the University of Chicago will be screened for eligibility.
NCT02203630 ↗ Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients Terminated National Center for Advancing Translational Science (NCATS) Phase 4 2014-08-01 Septic shock is a condition that is marked by severe infection causing hypotension requiring vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign, an international organization formed for the purpose of guiding the management of sepsis and septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate cardiac complications. This recommendation is based solely on experience with no scientific evidence to support this recommendation. The investigators will conduct an open-label randomized controlled trial (RCT) directly comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used in clinical practice for the management of septic shock. The investigators will perform this study with a population of patients that have septic shock to complete the following aims: Aim 1: Determine the incidence of tachyarrhythmias. Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a lower heart rate. Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a higher incidence of new tachyarrhythmias. Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less time in tachyarrhythmia. Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer complications, including cardiac complications. The investigators hypothesize that in this setting, phenylephrine will improve the management of septic shock when used as a "first choice" vasopressor by: 1. Decreasing the mean heart rate 2. Decreasing the incidence of new tachyarrhythmias 3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new onset and recurrent tachyarrhythmias 4. Decreasing the number of cardiac complications
NCT02203630 ↗ Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients Terminated National Center for Research Resources (NCRR) Phase 4 2014-08-01 Septic shock is a condition that is marked by severe infection causing hypotension requiring vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign, an international organization formed for the purpose of guiding the management of sepsis and septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate cardiac complications. This recommendation is based solely on experience with no scientific evidence to support this recommendation. The investigators will conduct an open-label randomized controlled trial (RCT) directly comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used in clinical practice for the management of septic shock. The investigators will perform this study with a population of patients that have septic shock to complete the following aims: Aim 1: Determine the incidence of tachyarrhythmias. Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a lower heart rate. Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a higher incidence of new tachyarrhythmias. Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less time in tachyarrhythmia. Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer complications, including cardiac complications. The investigators hypothesize that in this setting, phenylephrine will improve the management of septic shock when used as a "first choice" vasopressor by: 1. Decreasing the mean heart rate 2. Decreasing the incidence of new tachyarrhythmias 3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new onset and recurrent tachyarrhythmias 4. Decreasing the number of cardiac complications
NCT02203630 ↗ Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients Terminated Vanderbilt University Phase 4 2014-08-01 Septic shock is a condition that is marked by severe infection causing hypotension requiring vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign, an international organization formed for the purpose of guiding the management of sepsis and septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate cardiac complications. This recommendation is based solely on experience with no scientific evidence to support this recommendation. The investigators will conduct an open-label randomized controlled trial (RCT) directly comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used in clinical practice for the management of septic shock. The investigators will perform this study with a population of patients that have septic shock to complete the following aims: Aim 1: Determine the incidence of tachyarrhythmias. Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a lower heart rate. Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a higher incidence of new tachyarrhythmias. Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less time in tachyarrhythmia. Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer complications, including cardiac complications. The investigators hypothesize that in this setting, phenylephrine will improve the management of septic shock when used as a "first choice" vasopressor by: 1. Decreasing the mean heart rate 2. Decreasing the incidence of new tachyarrhythmias 3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new onset and recurrent tachyarrhythmias 4. Decreasing the number of cardiac complications
NCT02203630 ↗ Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients Terminated Vanderbilt University Medical Center Phase 4 2014-08-01 Septic shock is a condition that is marked by severe infection causing hypotension requiring vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign, an international organization formed for the purpose of guiding the management of sepsis and septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate cardiac complications. This recommendation is based solely on experience with no scientific evidence to support this recommendation. The investigators will conduct an open-label randomized controlled trial (RCT) directly comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used in clinical practice for the management of septic shock. The investigators will perform this study with a population of patients that have septic shock to complete the following aims: Aim 1: Determine the incidence of tachyarrhythmias. Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a lower heart rate. Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a higher incidence of new tachyarrhythmias. Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less time in tachyarrhythmia. Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer complications, including cardiac complications. The investigators hypothesize that in this setting, phenylephrine will improve the management of septic shock when used as a "first choice" vasopressor by: 1. Decreasing the mean heart rate 2. Decreasing the incidence of new tachyarrhythmias 3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new onset and recurrent tachyarrhythmias 4. Decreasing the number of cardiac complications
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Levophed

Condition Name

Condition Name for Levophed
Intervention Trials
Cesarean Section Complications 4
Septic Shock 2
Shock 2
Spinal Anesthetic Toxicity 2
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Condition MeSH

Condition MeSH for Levophed
Intervention Trials
Hypotension 5
Shock 3
Stroke 2
Ischemic Stroke 2
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Clinical Trial Locations for Levophed

Trials by Country

Trials by Country for Levophed
Location Trials
United States 7
Egypt 5
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Trials by US State

Trials by US State for Levophed
Location Trials
Massachusetts 1
Maryland 1
Ohio 1
Connecticut 1
West Virginia 1
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Clinical Trial Progress for Levophed

Clinical Trial Phase

Clinical Trial Phase for Levophed
Clinical Trial Phase Trials
Phase 4 8
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Levophed
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 3
Recruiting 2
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Clinical Trial Sponsors for Levophed

Sponsor Name

Sponsor Name for Levophed
Sponsor Trials
Cairo University 4
National Institutes of Health (NIH) 1
Wright State University 1
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Sponsor Type

Sponsor Type for Levophed
Sponsor Trials
Other 13
NIH 3
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LEVOPHED (Norepinephrine): Clinical Trials, Market Analysis, and Projections

Introduction

LEVOPHED, also known as norepinephrine, is a potent vasopressor used primarily in the management of septic shock, hypotension, and other critical care scenarios. This article will delve into recent clinical trials, market analysis, and projections for LEVOPHED, providing a comprehensive overview of its current and future standing in the pharmaceutical market.

Clinical Trials: Recent Developments

Early Norepinephrine in Sepsis

A significant clinical trial, the EA-NE-S-TUN study, has been designed to evaluate the efficacy of early administration of low-dose norepinephrine in adult patients with sepsis. This multicenter randomized clinical trial aims to compare the outcomes of patients receiving early norepinephrine versus standard care, particularly focusing on the control of shock within the first six hours of therapy. The trial meticulously monitors hemodynamic parameters, echocardiography, lactate levels, and other critical indicators to assess the effectiveness of norepinephrine in improving patient outcomes[1].

Vasopressin vs Norepinephrine in Septic Shock

The VANISH trial, conducted in the UK, compared the effects of vasopressin and norepinephrine on kidney failure in patients with septic shock. This factorial, double-blind, randomized clinical trial found that there was no significant difference in kidney failure-free days between patients treated with vasopressin and those treated with norepinephrine. However, the trial provided valuable insights into the management of septic shock and the role of vasopressors in critical care[4].

Market Analysis

Current Market Scenario

The norepinephrine market is part of the broader critical care pharmaceuticals segment, which is driven by the increasing need for effective treatments in intensive care units (ICUs). The market for norepinephrine is expected to grow due to its essential role in managing septic shock and other critical conditions.

Growth Projections

During the forecast period of 2020-2027, the norepinephrine medication market is anticipated to grow at a healthy rate. This growth is attributed to the increasing incidence of sepsis, advancements in critical care practices, and the expanding use of vasopressors in various clinical settings. The market expansion is also driven by the rising demand for effective treatments in ICUs and the growing awareness among healthcare professionals about the benefits of early intervention with norepinephrine[5].

Market Drivers

Increasing Incidence of Sepsis

The rising incidence of sepsis globally is a significant driver for the norepinephrine market. Sepsis is a life-threatening condition that requires immediate and effective treatment, and norepinephrine is a critical component of this treatment protocol.

Advancements in Critical Care

Advancements in critical care practices, including the early administration of vasopressors, have improved patient outcomes and increased the demand for norepinephrine. Clinical trials and guidelines that support the use of norepinephrine in septic shock management further bolster its market position.

Expanding Use in Clinical Settings

Norepinephrine is increasingly being used in various clinical settings beyond septic shock, such as in the management of hypotension and other critical care scenarios. This expanded use contributes to the growth of the norepinephrine market.

Competitive Landscape

Key Players

The market for norepinephrine is competitive, with several key players involved in its production and distribution. These companies focus on ensuring high-quality products and continuous supply to meet the growing demand in critical care settings.

Generic and Branded Products

Both generic and branded versions of norepinephrine are available in the market. Generic products offer a cost-effective alternative, while branded products often come with the assurance of quality and reliability. The presence of both types of products caters to different segments of the market.

Regulatory Environment

Approval and Guidelines

Norepinephrine is approved for use in various countries and is included in clinical guidelines for the management of septic shock and hypotension. Regulatory bodies continue to monitor its use and update guidelines based on new evidence from clinical trials.

Safety and Efficacy

The safety and efficacy of norepinephrine are closely monitored through post-marketing surveillance and ongoing clinical trials. This ensures that the drug remains a safe and effective option for critical care patients.

Future Outlook

Emerging Trends

The future of the norepinephrine market is influenced by emerging trends in critical care, including the integration of advanced monitoring technologies and personalized medicine approaches. These trends are expected to enhance the efficacy and safety of norepinephrine use.

Research and Development

Ongoing research and development in the field of critical care pharmacology are likely to lead to new indications and improved formulations of norepinephrine. This could further expand its market potential.

Key Takeaways

  • Clinical Trials: Recent trials like the EA-NE-S-TUN and VANISH studies highlight the importance of norepinephrine in septic shock management.
  • Market Growth: The norepinephrine market is projected to grow at a healthy rate due to increasing sepsis incidence and advancements in critical care.
  • Market Drivers: The market is driven by the rising demand for effective treatments in ICUs and the expanding use of vasopressors.
  • Competitive Landscape: The market includes both generic and branded products, ensuring a competitive and diverse market.
  • Regulatory Environment: Norepinephrine is closely monitored for safety and efficacy, with ongoing updates to clinical guidelines.

FAQs

What is the primary use of LEVOPHED (norepinephrine)?

LEVOPHED (norepinephrine) is primarily used in the management of septic shock, hypotension, and other critical care scenarios.

What are the key findings of the EA-NE-S-TUN trial?

The EA-NE-S-TUN trial evaluates the efficacy of early administration of low-dose norepinephrine in adult patients with sepsis, focusing on the control of shock within the first six hours of therapy.

How does the VANISH trial compare vasopressin and norepinephrine?

The VANISH trial compared the effects of vasopressin and norepinephrine on kidney failure in patients with septic shock and found no significant difference in kidney failure-free days between the two treatments.

What drives the growth of the norepinephrine market?

The growth of the norepinephrine market is driven by the increasing incidence of sepsis, advancements in critical care practices, and the expanding use of vasopressors in various clinical settings.

What is the projected market size for norepinephrine by 2027?

The norepinephrine medication market is expected to grow at a healthy rate during the forecast period of 2020-2027, though specific market size projections vary based on different analyses.

Sources

  1. Organic compound Norepinephrine / Classification: Organic compound.
  2. Multicenter randomized clinical trial (EA-NE-S-TUN) study protocol.
  3. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
  4. An update on the available medications and drugs under investigation.
  5. Effect of Early Vasopressin vs Norepinephrine on Kidney Failure in Patients with Septic Shock.
  6. Norepinephrine Drug Market research and analysis by expert.

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