CLINICAL TRIALS PROFILE FOR ACEBUTOLOL HYDROCHLORIDE

All Clinical Trials for acebutolol hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		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.
NCT00000522 ↗	Treatment of Mild Hypertension Study (TOMHS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1985-08-01	To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
NCT00000522 ↗	Treatment of Mild Hypertension Study (TOMHS)	Completed	University of Minnesota	Phase 2	1985-08-01	To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
NCT00000522 ↗	Treatment of Mild Hypertension Study (TOMHS)	Completed	University of Minnesota - Clinical and Translational Science Institute	Phase 2	1985-08-01	To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.

Clinical Trial Conditions for acebutolol hydrochloride

Condition Name

Condition Name for acebutolol hydrochloride
Intervention	Trials
Heart Failure	2
Heart Failure With Preserved Ejection Fraction	2
Heart Failure, Diastolic	2
Hypertension	2

Condition MeSH

Condition MeSH for acebutolol hydrochloride
Intervention	Trials
Heart Diseases	3
Heart Failure	2
Hypertension	2
Heart Failure, Diastolic	2

Clinical Trial Locations for acebutolol hydrochloride

Trials by Country

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Trials by Country for acebutolol hydrochloride
Location	Trials
United States	12
Canada	1
France	1
Korea, Republic of	1
Puerto Rico	1

Trials by US State

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−

Trials by US State for acebutolol hydrochloride
Location	Trials
New York	2
Virginia	1
Tennessee	1
Pennsylvania	1
Ohio	1

Clinical Trial Progress for acebutolol hydrochloride

Clinical Trial Phase

Clinical Trial Phase for acebutolol hydrochloride
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for acebutolol hydrochloride
Clinical Trial Phase	Trials
Completed	4
Enrolling by invitation	2
Terminated	1

Clinical Trial Sponsors for acebutolol hydrochloride

Sponsor Name

Sponsor Name for acebutolol hydrochloride
Sponsor	Trials
Weill Medical College of Cornell University	2
VA Office of Research and Development	1
Laval University	1

Sponsor Type

Sponsor Type for acebutolol hydrochloride
Sponsor	Trials
Other	11
U.S. Fed	2
NIH	2

Acebutolol Hydrochloride: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Efficacy

Acebutolol hydrochloride, a beta-blocker, has been extensively studied in various clinical trials to assess its efficacy and safety in treating cardiovascular conditions.

Beta-Blocking Activity

Clinical trials have demonstrated the beta-1 selective blocking activity of acebutolol. This is evident through the reduction in resting heart rate, decrease in exercise-induced tachycardia, reduction in cardiac output, and lowering of systolic and diastolic blood pressures at rest and post-exercise[1].

Specific Indications

Acebutolol has been tested in patients with hypertension, angina pectoris, and arrhythmias. For instance, 2059 hypertensive patients and 873 patients with angina received acebutolol hydrochloride during clinical trials. These trials showed that the drug was effective in managing these conditions, although some patients discontinued treatment due to adverse effects[3].

Adverse Reactions and Safety

Clinical trials have identified several adverse reactions associated with acebutolol hydrochloride, including congestive heart failure, severe bradycardia, bronchospasm, and third-degree A-V block. However, these serious adverse reactions occurred in less than 1% of the patients. Additionally, there was an increase in antinuclear antibody (ANA) titers in approximately 12.5% of patients, which was sometimes associated with clinical symptoms that resolved upon discontinuation of the drug[3].

Special Populations

Acebutolol has been used in elderly patients without specific dosage adjustments, although this population may require lower maintenance doses due to increased bioavailability of the drug and its metabolite. There is no experience with acebutolol in pediatric age groups, and its use in children is not recommended[1][3].

Market Analysis

The market for acebutolol hydrochloride is growing steadily, driven by several key factors.

Market Size and Projections

As of 2023, the acebutolol hydrochloride market was valued at USD 100 billion and is expected to reach USD 147.75 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031. This growth is attributed to the increasing prevalence of cardiovascular disorders such as hypertension and arrhythmias worldwide[2].

Segmentation

The market is segmented based on type (100mg, 200mg, 400mg) and application (hypertension, angina pectoris, arrhythmia), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The expanding access to healthcare, particularly in emerging nations, and the increasing use of beta-blockers in treating cardiac disorders are significant drivers of this market[2].

Demand and Growth Factors

The demand for acebutolol hydrochloride is fueled by the need for efficient treatment options for cardiovascular diseases. The medication's ability to regulate blood pressure and treat abnormal heart rhythms makes it a preferred choice among both patients and medical professionals. Continued research into the broader medicinal uses of acebutolol hydrochloride, such as its potential benefits for chronic heart failure, is expected to further drive market growth[2].

Market Trends and Outlook

Expanding Healthcare Infrastructure

The improvement in healthcare infrastructure, especially in developing countries, has made acebutolol hydrochloride more widely available. This increased accessibility is a significant factor contributing to the market's expansion[2].

Research and Development

Ongoing research into the potential benefits of acebutolol hydrochloride for other ailments is anticipated to expand its therapeutic applications. This continued innovation is expected to propel market growth and increase the drug's market penetration[2].

Regional Analysis

The market analysis includes a thorough examination of regional supply, demand, and key players. Regions such as Asia-Pacific and South America are expected to show significant growth due to increasing healthcare access and the rising prevalence of cardiovascular diseases[5].

Key Takeaways

• Clinical Efficacy: Acebutolol hydrochloride has demonstrated beta-1 selective blocking activity, making it effective in treating hypertension, angina pectoris, and arrhythmias.
• Adverse Reactions: While generally safe, the drug can cause serious adverse reactions in a small percentage of patients, including congestive heart failure and third-degree A-V block.
• Market Growth: The market for acebutolol hydrochloride is projected to grow at a CAGR of 5% from 2024 to 2031, driven by increasing demand for cardiovascular treatments and expanding healthcare infrastructure.
• Regional Expansion: Emerging markets, particularly in Asia-Pacific and South America, are expected to contribute significantly to the market's growth.

FAQs

Q: What are the primary indications for acebutolol hydrochloride?

A: Acebutolol hydrochloride is primarily used to treat hypertension, angina pectoris, and arrhythmias.

Q: What are the common adverse reactions associated with acebutolol hydrochloride?

A: Common adverse reactions include congestive heart failure, severe bradycardia, bronchospasm, and an increase in antinuclear antibody (ANA) titers.

Q: How does acebutolol hydrochloride affect the elderly population?

A: Elderly patients may require lower maintenance doses due to increased bioavailability of the drug and its metabolite, but it has been used successfully in this age group without specific dosage adjustments.

Q: What is the projected market size for acebutolol hydrochloride by 2031?

A: The market is expected to reach USD 147.75 billion by 2031, growing at a CAGR of 5% from 2024 to 2031.

Q: What factors are driving the growth of the acebutolol hydrochloride market?

A: The growth is driven by the increasing prevalence of cardiovascular disorders, expanding access to healthcare, and ongoing research into broader medicinal uses of the drug.

Sources

1. Drugs.com: Acebutolol: Package Insert / Prescribing Information.
2. MarketResearchIntellect: Acebutolol Hydrochloride Market Size and Projections.
3. Health Canada: PRODUCT MONOGRAPH APO-ACEBUTOLOL Acebutolol Tablets.
4. PubChem: Acebutolol Hydrochloride | C18H29ClN2O4 | CID 441307.
5. MarketPublishers: 2018 Global Acebutolol hydrochloride (CAS 34381-68-5) Industry Report.