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Last Updated: July 14, 2025

CLINICAL TRIALS PROFILE FOR DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER


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All Clinical Trials for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001895 ↗ Electromechanical Mapping to Evaluate Heart Muscle Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1999-08-01 Patients with narrowed heart arteries who undergo coronary angiography (imaging of the heart's blood vessels) may participate in this "heart mapping" study designed to gain information about the condition of different areas of the heart muscle. In coronary angiography, a thin tube called a catheter is inserted through a small incision in the groin and pushed up to the heart. There, a contrast dye is injected, revealing areas of blockage in the coronary arteries-the vessels that supply blood to the heart muscle. As soon as the angiography is completed, patients in this study will undergo another procedure called "Biosense mapping." For this procedure, a special catheter with a tiny sensor at the tip will be inserted into the sheath that was used for the angiography and advanced to the heart's main pumping chamber-the left ventricle. The sensor detects the pattern of an electromagnetic field generated from a pad under the patient, and an image of the precise location of the catheter in 3-dimensional space can be seen on a computer screen. The catheter is then navigated to various precise locations in the ventricle, producing an electromechanical map that distinguishes scarred muscle tissue from healthy tissue-information that can be important in guiding treatment. When this mapping is completed, the patient will be given a drug called dobutamine to increase the heartbeat, and the mapping will be repeated. The heart may also be mapped while the heart rate is increased with a pacing catheter to simulate exercise. The test will be stopped if adverse side effects develop. Patients in the study will also have magnetic resonance imaging (MRI) and PET (positron emission tomography) scans to get additional information about the heart muscle, such as blood flow and metabolism rate.
NCT00014040 ↗ Nitric Oxide Inhalation Therapy to Relieve Chest Pain in Patients With Coronary Artery Disease Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 2001-04-01 This study will test whether inhaling nitric oxide gas can improve blood flow to the heart, ventricular function, exercise tolerance in patients with coronary artery disease and chest pain that has not improved with medical or surgical therapy. Patients with coronary artery disease who have chest pain despite treatment with medicines and angioplasty or surgery may be eligible for this study. Those enrolled will receive monetary compensation for their participation in this study. The duration of the study is 5 days, with 2 testing periods lasting 2 days each. During one of the periods, the study participants will breathe nitric oxide mixed with room air through a face mask during the tests. During the other period, the participants will breathe room air alone through a face mask during the tests. At least 1 day will separate the treatment periods. During each of the 2 treatment periods (nitric oxide and room air), participants will undergo 4 tests to determine whether the treatment improves the heart's response to stress with increased heart rate and contraction. Approximately one hour before each of the tests, participants will breathe either nitric oxide mixed with room air or room air alone through the face mask, and continue the inhalation treatment while each test is being performed. The face mask will be removed at the end of each test. On the morning of the first day of each treatment period, participants will have a special echocardiogram with imaging of the heart. The echocardiogram will be performed during an infusion of dobutamine, a medicine that increases heart rate and contraction, and serves to stress the heart. This manner of stress testing is commonly used in hospitals around the country to determine if walls of the heart are receiving sufficient blood supply. That afternoon, participants will undergo a magnetic resonance imaging (MRI) study of the heart. The MRI will determine the heart's blood flow and contraction while receiving the same dosage of dobutamine as was used earlier in the day. On the morning of the second day of each treatment period, participants will exercise on a treadmill until moderately uncomfortable chest pain is reported. Later that morning, participants will undergo cardiac catheterization. For the cardiac catheterization, a long tube (catheter) will be placed into a vein of the neck once the skin is numbed with xylocaine. This tube will be positioned within the right atrium of the heart and into a tube-like structure called the coronary sinus, where venous blood exits the heart muscle. A small catheter will also be placed in an artery of the upper forearm after the skin has been numbed with xylocaine. Blood samples will be taken to allow us to measure the amount of nitric oxide transported in the blood. The blood samples will be drawn (through the tube in the heart and through the small tube in the artery) at the beginning of the study and during infusion of dobutamine to stress the heart. The dose of the dobutamine infusion will be the same dose used in the previous day's stress studies. After the completion of the first treatment period, we will stop testing for at least one day. Participants will begin the second treatment period with the inhalation treatment not received during the first treatment period.
NCT00060840 ↗ The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation Completed Mallinckrodt Phase 2 2003-07-01 The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following: - Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2 - Administration of ≥ 20 inotropic equivalents (IE) - 10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE - 0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE - 1 µg/kg/min milrinone is equivalent to 15 IE - 0.1 U/min vasopressin is equivalent to 10 IE - Mean arterial pressure (MAP) ≤ 55 mmHg - Central venous pressure (CVP) ≥ 16 mmHg - Percent mixed venous oxygen saturation (SvO2) ≤ 55% Or at least one of the following criteria: - Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean' - Death
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container

Condition Name

Condition Name for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container
Intervention Trials
Heart Failure 13
Cardiogenic Shock 11
Septic Shock 10
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Condition MeSH

Condition MeSH for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container
Intervention Trials
Heart Failure 29
Shock 22
Shock, Cardiogenic 12
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Clinical Trial Locations for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container
Location Trials
United States 57
France 47
Germany 13
Spain 8
United Kingdom 8
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Trials by US State

Trials by US State for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container
Location Trials
New York 5
California 5
Texas 5
Missouri 4
Illinois 4
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Clinical Trial Progress for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container
Clinical Trial Phase Trials
Phase 4 31
Phase 3 23
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container
Clinical Trial Phase Trials
Completed 60
Unknown status 17
Recruiting 14
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Clinical Trial Sponsors for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 6
Scios, Inc. 5
Orion Corporation, Orion Pharma 4
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Sponsor Type

Sponsor Type for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container
Sponsor Trials
Other 163
Industry 22
NIH 6
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Dobutamine Hydrochloride in Dextrose 5%: Clinical Trials, Market Analysis, and Projections

Last updated: January 9, 2025

Introduction

Dobutamine Hydrochloride is a synthetic catecholamine widely used in the treatment of heart failure, a condition where the heart is unable to pump blood effectively. Here, we will delve into the clinical trials, market analysis, and future projections for Dobutamine Hydrochloride in Dextrose 5% solution.

Clinical Trials and Approval

Dobutamine Hydrochloride was first approved by the United States Food and Drug Administration (FDA) in July 1978 and has since been approved in various countries worldwide. Clinical trials have consistently shown its efficacy in increasing heart muscle contractility and improving cardiac output, thereby alleviating symptoms such as shortness of breath and fatigue associated with heart failure[1].

Key Findings from Clinical Trials

  • Clinical studies have demonstrated that Dobutamine Hydrochloride can increase heart rate by 30 beats per minute or more in approximately 10% of adult patients, and it can increase blood pressure by 50 mm Hg or more in about 7.5% of patients[4].
  • There has been no significant evidence of drug interactions when Dobutamine Hydrochloride is administered concurrently with other drugs, including digitalis[3].

Market Analysis

The market for Dobutamine Hydrochloride is part of the broader cardiovascular medication market, which is characterized by intense competition, changing consumer preferences, and technological advancements.

Global Market Overview

The global Dobutamine Hydrochloride market is experiencing significant growth driven by factors such as increased demand for cardiovascular medications, rising disposable income, and advancements in technology. However, the market also faces challenges like changing consumer preferences, market saturation, and global economic instability[2].

Regional Market Dynamics

  • Asia-Pacific: This region is marked by rapid economic growth, increasing consumer spending, and a growing middle class. The regulatory environment is diverse, requiring businesses to adapt to different regulations and policies in each country[2].
  • Latin America: Characterized by a growing middle class, high levels of competition, and complex regulatory environments. Businesses must navigate these regulatory challenges and develop innovative products that meet local consumer preferences[2].
  • Europe and Americas: These regions also show significant demand for Dobutamine Hydrochloride, with market growth driven by the increasing prevalence of heart failure and the need for effective treatments[5].

Competitive Landscape

The market is highly competitive, with key players such as Eli Lilly & Co., N-Techem International, Poly Pharm, Shanghai Ziyuan Pharmaceutical, and Wuhan Plov Biology. The competition is driven by factors like product innovation, price, quality, brand recognition, and customer service[2].

Market Projections

Forecast by Region

Market research reports indicate that the global Dobutamine Hydrochloride market is expected to continue growing through 2029. Here are some key projections:

  • Global Market Size: The market is forecasted to grow significantly, driven by increasing demand and technological advancements. The global market size is expected to increase in value and volume across various regions[2][5].
  • Regional Forecasts: The Asia-Pacific region is expected to show rapid growth due to economic expansion and increasing healthcare spending. The Americas and Europe are also projected to see substantial growth, driven by the rising incidence of heart failure[2][5].

Market Drivers and Challenges

  • Drivers: Increased demand for cardiovascular medications, rising disposable income, and technological advancements are key drivers of the market[2].
  • Challenges: Changing consumer preferences, market saturation, and global economic instability are significant challenges that the market faces[2].

Impact of COVID-19 and Other Global Events

The COVID-19 pandemic and other global events, such as the Russia-Ukraine war, have had mixed impacts on the market. While there has been an increase in healthcare spending, supply chain disruptions and economic instability have posed challenges. However, the market is expected to recover and continue growing as these challenges are mitigated[2].

Product Details and Administration

Dobutamine Hydrochloride in Dextrose 5% is a sterile, nonpyrogenic solution intended for intravenous use only. It contains no antimicrobial agents and is stabilized with sodium bisulfite. The solution is available in various concentrations, and its administration rate is adjusted based on the patient's weight and clinical response[3].

Composition and Administration

  • Composition: The solution includes Dobutamine Hydrochloride and Dextrose Hydrous in Water for Injection, with adjustments made using sodium hydroxide and/or hydrochloric acid[3].
  • Administration: The drug delivery rate is calculated based on the patient's weight, and the solution is intended for single use only. Unused portions should be discarded[4].

Safety and Side Effects

While Dobutamine Hydrochloride is generally safe and effective, it can cause several side effects and interactions.

Common Side Effects

  • Cardiovascular Effects: It can precipitate or exacerbate ventricular ectopic activity and may cause rapid ventricular response in patients with atrial fibrillation[4].
  • Hypersensitivity Reactions: Skin rash, fever, eosinophilia, and bronchospasm have been reported occasionally. The presence of sodium bisulfite can cause allergic-type reactions, including anaphylactic symptoms and asthmatic episodes in susceptible individuals[4].

Key Takeaways

  • Clinical Efficacy: Dobutamine Hydrochloride has been proven effective in clinical trials for treating heart failure by increasing heart muscle contractility and improving cardiac output.
  • Market Growth: The global market is expected to grow driven by increasing demand for cardiovascular medications and technological advancements.
  • Regional Dynamics: The market is influenced by regional factors such as economic growth, consumer spending, and regulatory environments.
  • Product Safety: While generally safe, the drug can cause side effects and interactions, particularly in patients with preexisting conditions.

FAQs

What is Dobutamine Hydrochloride used for?

Dobutamine Hydrochloride is primarily used in the treatment of heart failure, a condition where the heart is unable to pump blood effectively.

Who developed Dobutamine Hydrochloride?

Dobutamine Hydrochloride was developed by Eli Lilly & Co., a renowned pharmaceutical company.

What are the common side effects of Dobutamine Hydrochloride?

Common side effects include cardiovascular effects such as ventricular ectopic activity, rapid ventricular response in atrial fibrillation, and hypersensitivity reactions including skin rash, fever, and bronchospasm.

How is Dobutamine Hydrochloride administered?

Dobutamine Hydrochloride in Dextrose 5% is administered intravenously, and the administration rate is adjusted based on the patient's weight and clinical response.

What are the market drivers for Dobutamine Hydrochloride?

The market is driven by increased demand for cardiovascular medications, rising disposable income, and technological advancements.

Sources

  1. A Comprehensive Review of dobutamine hydrochloride's R&D innovations - Synapse Patsnap Blog
  2. Dobutamine Hydrochloride Market: Rising Demand - OpenPR
  3. DOBUTamine Hydrochloride in 5% Dextrose Injection - FDA Label
  4. DOBUTamine Hydrochloride in 5% Dextrose Injection - FDA Label
  5. Global Dobutamine Hydrochloride Usp Consumption Market Research Report - Maia Research

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