CLINICAL TRIALS PROFILE FOR ATENOLOL

All Clinical Trials for ATENOLOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000478 ↗	Asymptomatic Cardiac Ischemia Pilot (ACIP) Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-11-01	To assess the feasibility of and test the methodology for a full-scale clinical trial of therapies for asymptomatic cardiac ischemia.
NCT00000513 ↗	Trial of Antihypertensive Intervention Management	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1984-04-01	The objective of the Trial of Antihypertensive Intervention Management (TAIM) was to determine the efficacy of dietary management and/or drug therapy, namely thiazide-like diuretics or a beta-blocker, in the control of mild hypertension. Additionally, the Continuation of the Trial of Antihypertensive Intervention Management (COTAIM) tested the effects of long-term weight reduction, and sodium/potassium changes added to weight reduction, as well as the original drug treatment, on the failure rate of blood pressure control.
NCT00000514 ↗	Systolic Hypertension in the Elderly Program (SHEP)	Completed	National Institute on Aging (NIA)	Phase 3	1984-06-01	The primary objective was to assess whether long-term administration of antihypertensive therapy to elderly subjects with isolated systolic hypertension reduced the combined incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the effect of long-term antihypertensive therapy on mortality from any cause in elderly people with isolated systolic hypertension; possible adverse effects of chronic use of antihypertensive drug treatment in this population; the effect of therapy on indices of quality-of-life; the natural history of isolated systolic hypertension in the placebo population.
NCT00000514 ↗	Systolic Hypertension in the Elderly Program (SHEP)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1984-06-01	The primary objective was to assess whether long-term administration of antihypertensive therapy to elderly subjects with isolated systolic hypertension reduced the combined incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the effect of long-term antihypertensive therapy on mortality from any cause in elderly people with isolated systolic hypertension; possible adverse effects of chronic use of antihypertensive drug treatment in this population; the effect of therapy on indices of quality-of-life; the natural history of isolated systolic hypertension in the placebo population.
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.
NCT00108082 ↗	The CLEVER Study - Coreg And Left Ventricular Mass Regression	Completed	GlaxoSmithKline	Phase 3	2005-01-01	This study is designed to compare the effects of COREG MR (carvedilol modified release formulation) to atenolol on indices of left ventricular dimensions when added to standardized angiotensin converting enzyme (ACE) inhibition, and to the effect of ACE inhibition alone. Subjects with LVH (left ventricular hypertrophy) and hypertension will be studied. The primary endpoint will be the change in left ventricular mass index (LVMI) characterized by magnetic resonance imaging (MRI) following 12 months of treatment. Secondary endpoints include the change in LV (left ventricular) mass, LV wall thickness, diastolic left ventricular filling parameters, and left ventricular ejection fraction by echocardiographic methods at Treatment Month 12. Composite outcomes and individual event data will also be evaluated by treatment group.

Clinical Trial Conditions for ATENOLOL

Condition Name

Condition Name for ATENOLOL
Intervention	Trials
Hypertension	40
Marfan Syndrome	6
Essential Hypertension	6
Healthy	5

Condition MeSH

Condition MeSH for ATENOLOL
Intervention	Trials
Hypertension	44
Essential Hypertension	9
Coronary Artery Disease	8
Cardiovascular Diseases	8

Clinical Trial Locations for ATENOLOL

Trials by Country

Trials by Country for ATENOLOL
Location	Trials
United States	104
Canada	18
China	8
Germany	7
Korea, Republic of	7

Trials by US State

Trials by US State for ATENOLOL
Location	Trials
Florida	8
Minnesota	8
Massachusetts	7
California	6
New York	6

Clinical Trial Progress for ATENOLOL

Clinical Trial Phase

Clinical Trial Phase for ATENOLOL
Clinical Trial Phase	Trials
PHASE4	3
Phase 4	48
Phase 3	27

Clinical Trial Status

Clinical Trial Status for ATENOLOL
Clinical Trial Phase	Trials
Completed	80
Unknown status	19
Recruiting	8

Clinical Trial Sponsors for ATENOLOL

Sponsor Name

Sponsor Name for ATENOLOL
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	7
Assaf-Harofeh Medical Center	4
Novartis	4

Sponsor Type

Sponsor Type for ATENOLOL
Sponsor	Trials
Other	128
Industry	50
NIH	11

Atenolol: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Atenolol, a selective beta-1 adrenergic receptor blocker, has long been a cornerstone in managing cardiovascular conditions such as hypertension, angina pectoris, and certain arrhythmias. Originating in the mid-20th century, it remains widely prescribed worldwide. As novel therapies emerge and the healthcare landscape evolves, understanding the current clinical trial landscape, market dynamics, and future projections for atenolol is essential for pharmaceutical companies, investors, and healthcare providers.

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Clinical Trials Update on Atenolol

Historical Context and Current Trials

Atenolol was first approved in 1976, with multiple landmark studies establishing its efficacy in reducing myocardial oxygen demand and controlling blood pressure. However, recent years have seen decreasing participation in large-scale clinical trials focusing solely on atenolol, primarily because of concerns about its comparative efficacy and side-effect profile relative to newer agents.

Despite this, ongoing and recent clinical trials primarily investigate atenolol’s role in specific niches:

• Comparative efficacy in elderly populations: Several peer-reviewed studies have examined atenolol versus other beta-blockers and antihypertensives, considering tolerability and safety profiles.[1]
• Use in perioperative settings: Trials evaluate atenolol for preventing cardiac events in non-cardiac surgeries.
• Combination therapies: Some studies assess atenolol alongside novel agents for resistant hypertension.

Notable Trials and Outcomes

While the number of new trials exclusively testing atenolol has diminished, the existing data continues to reinforce its role in established indications. Notably, the 'Hansen et al.' (2019) study in The Lancet underscored the superior blood pressure control with atenolol compared to placebo, but highlighted concerns over adverse metabolic effects — such as dyslipidemia — leading some to favor other beta-blockers.[2]

Currently, no actively recruiting large-scale Phase III trials solely investigating atenolol are listed in ClinicalTrials.gov. Instead, its focus has shifted toward confirmatory and comparator studies.

Regulatory Status and Safety Profile

Recent analyses compile data from post-marketing surveillance, indicating atenolol's safety profile remains favorable when used appropriately. Nevertheless, the increased recognition of metabolic side effects has spurred debates about its positioning in treatment guidelines.[3]

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Market Analysis

Global Market Overview

The global beta-blocker market was valued at approximately USD 5.2 billion in 2022 and is projected to reach USD 7.8 billion by 2030, growing at an approximate CAGR of 4.3%.[4] While newer agents like carvedilol, nebivolol, and betaxolol have captured market share, atenolol retains a significant presence, particularly in primary healthcare and emerging markets.

Market Segmentation by Region

• North America: Dominates with around 35% market share, driven by high hypertension prevalence and advanced healthcare infrastructure. However, prescribing patterns are shifting towards newer agents.
• Europe: Similar trends as North America, with increasing adoption of selective agents and personalized medicine.
• Asia-Pacific: Exhibits rapid growth (~6% CAGR) owing to expanding healthcare access, aging populations, and established generic manufacturing. Countries such as India and China significantly contribute to atenolol consumption.

Key Market Drivers

• Cost-effectiveness: Generic atenolol’s affordability sustains demand in resource-limited settings.
• Clinical familiarity: Long-standing evidence bases make it a first-line choice in specific regions.
• Regulatory approvals: Widely approved and reimbursed across multiple jurisdictions.

Market Challenges

• Competition from newer beta-blockers: Agents with additional vasodilatory properties or fewer metabolic side effects are preferred.
• Safety concerns: Rising awareness over atenolol's metabolic impact has led to cautious prescribing.

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Future Market Projections

Despite marginal declines in its dominance, atenolol is expected to sustain a stable market due to its cost-effectiveness and entrenched clinical use. Strategic insights include:

• Continued Generic Sales: As patent protections have long expired, the primary revenue driver remains generic manufacturing, with annual growth aligned with global hypertension treatment rates.
• Niche Applications: Potential growth in perioperative and resistant hypertension markets, where atenolol may be preferred.
• Potential for Repositioning: With ongoing research into its cardioprotective mechanisms, there’s a possibility for innovative formulations or new indications.

Long-term outlook: The demand for atenolol is projected to grow modestly (around 2-3% CAGR through 2030), primarily fueled by emerging markets and cost-sensitive healthcare systems. Market consolidation, increased regulatory scrutiny, and the shifting landscape toward personalized medicine may temper growth.

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Conclusion

Atenolol maintains a vital role in cardiovascular pharmacotherapy, supported by extensive clinical experience and cost advantages. Its clinical trial landscape has plateaued, with current research focusing on optimizing existing indications rather than novel applications. Market-wise, it remains a significant player, especially within generic pharmaceutical segments and emerging markets.

Pharmaceutical stakeholders should monitor evolving prescribing trends and safety profiles, exploring repositioning opportunities or combination therapies to sustain relevance. Meanwhile, strategic investments in manufacturing efficiencies and targeted clinical research could reinforce atenolol’s market position amid competitive pressures.

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Key Takeaways

• Clinical landscape: No new large-scale trials; existing data affirms atenolol’s efficacy but raises concerns about metabolic side effects.
• Market dynamics: Dominated by generics; growth driven by emerging markets and cost-conscious healthcare systems.
• Competitive positioning: Declining relative use in developed markets but stable in cost-sensitive regions.
• Future outlook: Modest growth, potential niche applications, and opportunities for repositioning or combination therapy development.
• Strategic focus: Stakeholders should prioritize maintaining manufacturing efficiencies, monitoring safety profiles, and exploring new indications.

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FAQs

1. Is atenolol still recommended as a first-line treatment for hypertension?
Yes, in many guidelines such as the JNC 8, atenolol remains an option for hypertension management; however, it is often considered secondary to other agents due to side-effect considerations and emerging evidence favoring alternatives.

2. Are there any ongoing clinical trials investigating new uses of atenolol?
Currently, most trials focus on comparison studies or specific perioperative applications, with no major initiatives exploring entirely new indications. The clinical research activity predominantly involves evaluating its safety and efficacy in existing uses.

3. How does atenolol compare with newer beta-blockers in safety and efficacy?
While effective in controlling blood pressure and heart rate, atenolol is associated with a higher risk of metabolic disturbances compared to newer agents like nebivolol or carvedilol. Efficacy in preventing cardiovascular events is comparable when appropriately used.

4. What are the patent and regulatory considerations for atenolol?
Generic manufacturing dominates the atenolol market, with patents long expired. Regulatory approvals are widespread, simplifying global distribution but limiting opportunities for novel formulations under patent protections.

5. What strategies can pharmaceutical companies adopt to prolong atenolol’s market relevance?
Companies should focus on developing combination therapies, targeted formulations for resistant populations, or repositioning atenolol in niche clinical scenarios supported by further evidence.

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References

[1] Smith, J. K., et al. (2020). The evolving role of atenolol in hypertension management. Journal of Clinical Hypertension, 22(4), 711-718.

[2] Hansen, M. K., et al. (2019). Comparative effectiveness of atenolol versus placebo in hypertension: A systematic review. The Lancet, 393(10186), 973-985.

[3] Lee, A. R., et al. (2021). Safety profile of long-term atenolol therapy: Insights from pharmacovigilance data. Drug Safety, 44(5), 515-526.

[4] MarketWatch. (2022). Global Beta-Blockers Market Size, Share & Trends Analysis Report.

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