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Last Updated: May 18, 2025

CLINICAL TRIALS PROFILE FOR LABETALOL HYDROCHLORIDE IN DEXTROSE


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All Clinical Trials for Labetalol Hydrochloride In Dextrose

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000291 ↗ Effects of Labetalol on Human Cocaine Use - 8 Completed University of Minnesota Phase 2 1997-10-01 The purpose of this study is to determine the effect of labetalol treatment on the subjective and physiological effects of cocaine.
NCT00000291 ↗ Effects of Labetalol on Human Cocaine Use - 8 Completed University of Minnesota - Clinical and Translational Science Institute Phase 2 1997-10-01 The purpose of this study is to determine the effect of labetalol treatment on the subjective and physiological effects of cocaine.
NCT00000291 ↗ Effects of Labetalol on Human Cocaine Use - 8 Completed National Institute on Drug Abuse (NIDA) Phase 2 1997-10-01 The purpose of this study is to determine the effect of labetalol treatment on the subjective and physiological effects of cocaine.
NCT00000297 ↗ Effects of Labetalol on Nicotine Administration in Humans - 14 Completed University of Minnesota Phase 2 1998-10-01 The purpose of this study is to investigate the effects of labetalol in response to intravenous nicotine
NCT00000297 ↗ Effects of Labetalol on Nicotine Administration in Humans - 14 Completed University of Minnesota - Clinical and Translational Science Institute Phase 2 1998-10-01 The purpose of this study is to investigate the effects of labetalol in response to intravenous nicotine
NCT00000297 ↗ Effects of Labetalol on Nicotine Administration in Humans - 14 Completed National Institute on Drug Abuse (NIDA) Phase 2 1998-10-01 The purpose of this study is to investigate the effects of labetalol in response to intravenous nicotine
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed US Department of Veterans Affairs 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Labetalol Hydrochloride In Dextrose

Condition Name

Condition Name for Labetalol Hydrochloride In Dextrose
Intervention Trials
Hypertension in Pregnancy 7
Hypertension 6
Preeclampsia 6
Pre-Eclampsia 3
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Condition MeSH

Condition MeSH for Labetalol Hydrochloride In Dextrose
Intervention Trials
Hypertension 23
Pre-Eclampsia 21
Hypertension, Pregnancy-Induced 16
Eclampsia 8
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Clinical Trial Locations for Labetalol Hydrochloride In Dextrose

Trials by Country

Trials by Country for Labetalol Hydrochloride In Dextrose
Location Trials
United States 40
Egypt 11
Canada 7
India 2
China 2
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Trials by US State

Trials by US State for Labetalol Hydrochloride In Dextrose
Location Trials
New York 11
Ohio 4
California 4
Texas 3
Tennessee 3
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Clinical Trial Progress for Labetalol Hydrochloride In Dextrose

Clinical Trial Phase

Clinical Trial Phase for Labetalol Hydrochloride In Dextrose
Clinical Trial Phase Trials
Phase 4 24
Phase 3 6
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Labetalol Hydrochloride In Dextrose
Clinical Trial Phase Trials
Completed 28
Recruiting 13
Unknown status 8
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Clinical Trial Sponsors for Labetalol Hydrochloride In Dextrose

Sponsor Name

Sponsor Name for Labetalol Hydrochloride In Dextrose
Sponsor Trials
Weill Medical College of Cornell University 3
University of Alberta 3
Mansoura University 3
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Sponsor Type

Sponsor Type for Labetalol Hydrochloride In Dextrose
Sponsor Trials
Other 83
NIH 4
U.S. Fed 4
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Labetalol Hydrochloride in Dextrose: Clinical Trials, Market Analysis, and Projections

Introduction

Labetalol Hydrochloride is a versatile antihypertensive drug that has been widely used for decades to manage severe hypertension. Here, we will delve into the clinical trials, market analysis, and future projections for Labetalol Hydrochloride in Dextrose.

Clinical Trials and Development

Historical Approval and Development

Labetalol Hydrochloride was first approved in Japan in October 1982 and has since received global approval. The drug was developed by GSK Plc, a renowned pharmaceutical company, and has undergone rigorous testing and clinical trials to demonstrate its safety and efficacy[3].

Mechanism of Action

Labetalol Hydrochloride combines selective alpha1-adrenergic and nonselective beta-adrenergic blocking activities. In humans, the ratio of alpha- to beta-blockade is approximately 1:7 following intravenous administration. This dual action contributes significantly to its effectiveness in lowering blood pressure[1][4].

Clinical Trials Outcomes

Clinical trials have shown that Labetalol Hydrochloride is effective in reducing blood pressure in severe hypertensive patients. For instance, an initial 0.25 mg/kg injection of labetalol HCl administered to patients in the supine position decreased blood pressure by an average of 11/7 mmHg[1].

Market Analysis

Current Market Position

Labetalol Hydrochloride in Dextrose is indicated for the treatment of severe hypertension and is available in various formulations, including ready-to-use solutions and prefilled syringes. Its market presence is strong due to its efficacy and the lack of significant adverse effects in most patients[1][2].

Market Size and Growth

The global antihypertensive market is growing, driven by increasing prevalence of hypertension and the need for effective management options. Labetalol Hydrochloride, being a well-established drug, holds a significant share in this market. The market size for antihypertensive drugs is projected to continue growing, with Labetalol Hydrochloride expected to remain a key player due to its proven track record and versatility in different clinical settings.

Competitive Landscape

The antihypertensive market is highly competitive, with various drugs available, including other beta-blockers and calcium channel blockers. However, Labetalol Hydrochloride's unique dual-action mechanism sets it apart, making it a preferred choice in certain clinical scenarios, such as severe hypertension and pheochromocytoma[4].

Market Projections

Future Demand

The demand for Labetalol Hydrochloride in Dextrose is expected to remain strong due to the increasing global prevalence of hypertension. According to the World Health Organization (WHO), hypertension affects over a billion people worldwide, and this number is projected to increase, driving the demand for effective antihypertensive medications.

Emerging Markets

Emerging markets, particularly in Asia and Latin America, are expected to contribute significantly to the growth of the antihypertensive market. As healthcare infrastructure improves and access to medications increases in these regions, the demand for Labetalol Hydrochloride is likely to rise.

Innovations and Formulations

While the current formulations of Labetalol Hydrochloride in Dextrose are effective, there is ongoing research into new delivery systems and formulations that could enhance patient compliance and efficacy. For example, extended-release formulations or combination therapies could further solidify Labetalol Hydrochloride's position in the market.

Dosage and Administration

Recommended Dosage

Labetalol Hydrochloride in Dextrose is administered as a slow continuous infusion at a rate of 2 mL/min (2 mg/min) or as bolus injections of 0.25 mg/kg (up to a maximum of 20 mg) over 2 minutes, with additional injections of 40 or 80 mg given at 10-minute intervals if necessary[1][2].

Formulations

The drug is available in single-dose bags of 100 mL, 200 mL, and 300 mL for both sodium chloride and dextrose solutions, as well as in prefilled syringes. These formulations are ready-to-use and do not require further dilution[1][2].

Safety and Contraindications

Adverse Effects

Most adverse effects of Labetalol Hydrochloride are mild and transient. However, significant side effects can include symptomatic postural hypotension, and the drug may mask tachycardia associated with hypoglycemia in diabetic patients[1][2].

Contraindications

Labetalol Hydrochloride is contraindicated in patients with bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, and hypersensitivity reactions to labetalol[2][4].

Patient Counseling Information

Patients should be informed about the potential for symptomatic postural hypotension and the need to monitor glycemic levels if they are diabetic. They should also be advised on the signs of hypoglycemia that may not be masked by the drug[2].

Key Takeaways

  • Clinical Trials: Labetalol Hydrochloride has undergone rigorous clinical trials demonstrating its safety and efficacy in managing severe hypertension.
  • Market Analysis: The drug holds a significant position in the antihypertensive market due to its dual-action mechanism and proven track record.
  • Market Projections: The demand for Labetalol Hydrochloride is expected to grow, driven by the increasing prevalence of hypertension globally.
  • Dosage and Administration: The drug is available in various formulations and is administered via slow continuous infusion or bolus injections.
  • Safety and Contraindications: While generally well-tolerated, the drug has specific contraindications and potential side effects that need to be monitored.

FAQs

What is the primary indication for Labetalol Hydrochloride in Dextrose?

Labetalol Hydrochloride in Dextrose is primarily indicated for the treatment of severe hypertension to lower blood pressure[1][2].

How is Labetalol Hydrochloride in Dextrose administered?

It is administered as a slow continuous infusion at a rate of 2 mL/min (2 mg/min) or as bolus injections of 0.25 mg/kg (up to a maximum of 20 mg) over 2 minutes[1][2].

What are the contraindications for Labetalol Hydrochloride?

The drug is contraindicated in patients with bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, and hypersensitivity reactions to labetalol[2][4].

Can Labetalol Hydrochloride mask symptoms of hypoglycemia?

Yes, Labetalol Hydrochloride can mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be masked[2].

What is the expected market growth for Labetalol Hydrochloride?

The market for Labetalol Hydrochloride is expected to grow due to the increasing global prevalence of hypertension and the drug's proven efficacy and safety profile[3].

Sources

  1. FDA Label: Labetalol Hydrochloride Injection - Full Prescribing Information[1].
  2. FDA Label: LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE INJECTION and LABETALOL HYDROCHLORIDE IN DEXTROSE INJECTION[2].
  3. Synapse: An In-depth Analysis of Labetalol Hydrochloride's R&D Progress and Mechanism of Action on Drug Target[3].
  4. DailyMed: LABETALOL HYDROCHLORIDE injection[4].
Last updated: 2025-01-01

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