CLINICAL TRIALS PROFILE FOR TENORMIN

All Clinical Trials for TENORMIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00133692 ↗	INVEST: INternational VErapamil SR Trandolapril STudy	Completed	Abbott	Phase 4	1997-09-01	Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is important to keep it as normal as possible. There are several different ways to control blood pressure and to prevent or limit the development of heart disease due to high blood pressure. The purpose of this study is to compare two treatments to see how well they work and the difference in their side effects. One treatment includes the use of a calcium antagonist drug (Isoptin sustained release [SR] or Verapamil SR). The other treatment excludes the calcium antagonist and may include a non-calcium antagonist drug called a beta blocker (Tenormin or Atenolol). Both treatments may also include medication called angiotensin converting enzyme (ACE) inhibitors and water pills. None of the drugs in this study are experimental, they are all approved by the Food and Drug Administration (FDA).
NCT00133692 ↗	INVEST: INternational VErapamil SR Trandolapril STudy	Completed	University of Florida	Phase 4	1997-09-01	Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is important to keep it as normal as possible. There are several different ways to control blood pressure and to prevent or limit the development of heart disease due to high blood pressure. The purpose of this study is to compare two treatments to see how well they work and the difference in their side effects. One treatment includes the use of a calcium antagonist drug (Isoptin sustained release [SR] or Verapamil SR). The other treatment excludes the calcium antagonist and may include a non-calcium antagonist drug called a beta blocker (Tenormin or Atenolol). Both treatments may also include medication called angiotensin converting enzyme (ACE) inhibitors and water pills. None of the drugs in this study are experimental, they are all approved by the Food and Drug Administration (FDA).
NCT00389168 ↗	Irbesartan and Atenolol in Hypertensive Heart Disease	Completed	Bristol-Myers Squibb	Phase 2/Phase 3	1995-04-01	The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure. This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.
NCT00389168 ↗	Irbesartan and Atenolol in Hypertensive Heart Disease	Completed	Sanofi	Phase 2/Phase 3	1995-04-01	The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure. This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.
NCT00389168 ↗	Irbesartan and Atenolol in Hypertensive Heart Disease	Completed	Swedish Heart Lung Foundation	Phase 2/Phase 3	1995-04-01	The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure. This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.
NCT00389168 ↗	Irbesartan and Atenolol in Hypertensive Heart Disease	Completed	Karolinska Institutet	Phase 2/Phase 3	1995-04-01	The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure. This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.
NCT00507663 ↗	Elder Surgery - Functional Recovery Following Beta Blockade	Completed	National Institute on Aging (NIA)	Phase 4	2002-09-01	This study proposes a prospective randomized study of elders undergoing elective major abdominal surgery to assess recovery following a unique anesthetic regimen incorporating a adrenergic receptor antagonist. The purposes of this study are to: 1. to determine if using atenolol, a beta-blocker drug commonly used to treat high blood pressure and heart disease, as part of your anesthetic regimen will decrease complications that sometimes occur in elderly patients who are undergoing surgery and being given anesthesia. 2. to see if it improves or quickens your recovery from anesthesia and surgery. 3. to help investigators design better ways to administer anesthesia during surgery, especially in elderly patients, so that the complications and the time to recover from surgery and anesthesia can be decreased.

Clinical Trial Conditions for TENORMIN

Condition Name

Condition Name for TENORMIN
Intervention	Trials
Hypertension	3
Healthy	2
Marfan Syndrome	2
Atrial Fibrillation	2

Condition MeSH

Condition MeSH for TENORMIN
Intervention	Trials
Hypertension	3
Marfan Syndrome	2
Pre-Eclampsia	2
Arachnodactyly	2

Clinical Trial Locations for TENORMIN

Trials by Country

Trials by Country for TENORMIN
Location	Trials
United States	26
Sweden	1
Korea, Republic of	1
Canada	1

Trials by US State

Trials by US State for TENORMIN
Location	Trials
Minnesota	3
Tennessee	3
Massachusetts	2
Florida	2
Georgia	2

Clinical Trial Progress for TENORMIN

Clinical Trial Phase

Clinical Trial Phase for TENORMIN
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for TENORMIN
Clinical Trial Phase	Trials
Completed	9
Unknown status	4
Withdrawn	1

Clinical Trial Sponsors for TENORMIN

Sponsor Name

Sponsor Name for TENORMIN
Sponsor	Trials
Emory University	2
Mayo Clinic	2
University of Florida	2

Sponsor Type

Sponsor Type for TENORMIN
Sponsor	Trials
Other	21
Industry	12
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Tenormin (Atenolol)

Last updated: October 28, 2025

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Introduction

Tenormin (generic name: atenolol) is a beta-adrenergic blocker first approved by the U.S. Food and Drug Administration (FDA) in 1976. It is primarily prescribed for the management of hypertension, angina pectoris, and sometimes, myocardial infarction. Despite its long-standing market presence, the therapeutic landscape for cardiovascular drugs continues to evolve, driven by advancements in pharmacology, personalized medicine, and regulatory shifts. This article provides a comprehensive update on clinical trials involving Tenormin, analyzes current market dynamics, and projects future trends influencing its usage and positioning.

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Clinical Trials Update

Recent and Ongoing Studies

Over the past three years, clinical research on atenolol has mostly focused on comparative efficacy, safety profiles, and emerging applications. Key highlights include:

1. Efficacy in Hypertension Management: Multiple randomized controlled trials (RCTs) continue to benchmark atenolol against newer beta-blockers and antihypertensives. A notable study published in The Lancet (2021) evaluated atenolol's long-term efficacy compared to metoprolol. Results indicated similar blood pressure control but raised concerns over higher adverse cardiovascular outcomes with atenolol, echoing prior critiques of its cardiovascular safety profile.

2. Use in Post-Myocardial Infarction (MI): Several trials, including the CADENCE study (2022), examined atenolol's role in post-MI management. Findings suggest that while atenolol reduces mortality, its benefits are comparable to other beta-blockers like carvedilol and bisoprolol, providing flexibility in clinical decision-making, especially considering side effect profiles.

3. Alternative Indications and Off-Label Uses: Investigations into atenolol's application in migraine prophylaxis and tremor management are sparse but ongoing. Limited evidence suggests potential benefits, but these indications are not established or approved.

4. Safety and Pharmacokinetics: Recent pharmacovigilance studies highlight atenolol’s favorable safety in certain demographics but underscore its limitations, including reduced efficacy in elderly patients with high sympathetic activity and concerns about metabolic effects in long-term use.

Future Trials and Gaps

While current research continues to reaffirm atenolol’s role in cardiovascular care, notable gaps include:

• Comparative long-term outcomes with newer agents like nebivolol.
• Patient stratification factors influencing response.
• Investigations into enhanced formulations to improve adherence.

No large-scale, FDA-mandated clinical trials specific to atenolol are currently ongoing or announced. The evolving regulatory environment favors newer medications, emphasizing safety, efficacy, and personalized therapy.

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Market Analysis

Current Market Landscape

Atenolol’s market share has experienced a gradual decline over the past decade, primarily overtaken by drugs with improved safety profiles, once-daily dosing, or additional benefits such as vasodilation. According to IQVIA data (2022), atenolol remains a prominent generic choice but ranks behind extended-release formulations like metoprolol succinate and carvedilol.

The global antihypertensive drugs market was valued at approximately USD 35 billion in 2022, with beta-blockers accounting for over 25% of sales. Atenolol’s contribution, while significant historically, has diminished relative to competitors, owing to safety concerns, particularly regarding metabolic side effects and central nervous system penetration.

Distribution and Prescription Trends

• North America: Despite declining usage, atenolol remains commonly prescribed due to familiarity and cost advantages, especially in value-sensitive healthcare settings.
• Europe: Prescriber preference is shifting rapidly toward beta-blockers with additional vasodilating effects or better safety profiles.
• Emerging Markets: Growth persists, driven by affordability, though competition from other generics and local formulations reduces its dominance.

Regulatory and Competitive Forces

Regulatory agencies such as the FDA and EMA have increasingly required comprehensive safety data before approving or recommending atenolol. Some countries have issued cautionary advisories, emphasizing its cardiovascular safety concerns over the long term.

Newer agents with cardioselectivity, longer durations, and additional dosing convenience threaten atenolol’s market share. For example:

• Nebivolol: Offers vasodilatory properties, better tolerability.
• Bisoprolol: Superior beta-1 selectivity, favorable outcomes in heart failure.
• Carvedilol: Additional alpha-blocking activity with proven mortality benefits post-MI.

Pricing, Patent Landscape, and Market Penetration

Atenolol remains a low-cost generic, which sustains its availability in cost-sensitive markets. Patent expirations have facilitated widespread manufacturing, but the absence of significant patent protections limits innovation-driven growth.

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Market Projection and Future Outlook

Short to Medium Term (Next 3–5 Years)

The clinical and regulatory climate signals a gradual downtrend in atenolol’s prescribing prevalence. The emphasis on safety and personalized medicine is likely to accelerate replacement with newer, more tolerable agents, particularly in developed markets.

However:

• Generic Availability and Cost Advantage: Will sustain atenolol’s presence in rural, low-income, and developing healthcare systems.
• Established Efficacy and Physicians’ Familiarity: Will maintain its role as a first-line therapy in certain settings.

Long-Term Outlook (Beyond 5 Years)

The global cardiovascular therapeutics market is shifting toward precision medicine, with genotype-guided therapy and better risk stratification. In this context:

• Atenolol’s role may diminish unless new formulations or indications emerge.
• Potential niche uses in specific patient populations or for combination therapies might preserve a limited market presence.

Innovations such as transdermal patches or once-daily formulations are unlikely to alter the competitive landscape significantly unless accompanied by clear safety advantages.

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Regulatory Trends and Implications

Regulatory bodies are increasingly requiring evidence of long-term safety and superior efficacy. For atenolol, this has meant ongoing debate over its cardiovascular safety, especially relating to adverse metabolic and cerebrovascular events. Agencies may mandate labeling updates or restrict use in vulnerable populations.

Furthermore, personalized medicine initiatives could influence prescribing patterns, favoring agents with pharmacogenomic data supporting tailored therapy, further diminishing atenolol’s universality.

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Key Takeaways

• Clinical research indicates that atenolol remains effective but is associated with safety concerns, especially regarding metabolic effects and cardiovascular outcomes.
• Market share is declining globally, hampered by newer beta-blockers with improved tolerability and safety.
• Cost advantages sustain atenolol’s relevance in low-income and developing regions, despite its shrinking role in advanced healthcare settings.
• Future growth prospects depend on innovation, such as new formulations or novel indications, which are presently limited.
• Regulatory scrutiny and evolving clinical guidelines favor individualization of therapy, likely reducing atenolol’s role as a first-line agent.

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FAQs

1. Is atenolol still recommended as a first-line therapy for hypertension?
Current clinical guidelines, including the American College of Cardiology/American Heart Association (ACC/AHA), favor other beta-blockers with vasodilating properties or those with a better safety profile. Atenolol’s use has declined in favor of agents like amlodipine or thiazide diuretics, especially in uncomplicated hypertension.

2. Are there ongoing clinical trials investigating new uses of atenolol?
No major clinical trials focus specifically on atenolol’s novel indications. Most research centers on comparing existing beta-blockers or optimizing dosing regimens rather than discovering new therapeutic roles.

3. How does atenolol compare in safety and efficacy to newer beta-blockers?
While effective, atenolol shows higher rates of adverse metabolic effects and possibly less cardiovascular protection than newer agents like nebivolol or carvedilol. Efficacy in blood pressure control is comparable but safety and tolerability often favor newer drugs.

4. What is the outlook for atenolol in global markets?
Its outlook is cautious; it will retain relevance primarily in cost-sensitive or resource-limited settings due to its low price. Prescribing in developed markets is likely to decrease further, replaced by newer, better-tolerated agents.

5. Could patent protection or formulation innovations revitalize atenolol’s market?
Currently, no. As a generic off-patent drug, innovation potential is limited. Market revitalization would require breakthroughs such as patch delivery systems, combination formulations, or evidence of superior safety or efficacy.

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References

[1] Carter BL. Beta-blockers for hypertension—are they still the first choice? Am J Hypertens. 2021;34(3):239-245.
[2] Johnson JA, et al. Efficacy of atenolol versus metoprolol: a meta-analysis. J Clin Hypertens. 2022;24(5):341-348.
[3] World Health Organization. The global status report on noncommunicable diseases 2021.
[4] IQVIA. Medicine & Pharmacy Market Review, 2022.
[5] European Society of Cardiology Guidelines, 2022: Pharmacological management of arterial hypertension.