CLINICAL TRIALS PROFILE FOR LOPRESSOR

All Clinical Trials for LOPRESSOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00123604 ↗	Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes	Completed	GlaxoSmithKline	Phase 4	2004-06-01	The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.
NCT00123604 ↗	Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes	Completed	St. Paul Heart Clinic	Phase 4	2004-06-01	The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00246519 ↗	Pharmacogenomic Evaluation of Antihypertensive Responses	Completed	University of Florida	Phase 4	2005-10-01	There are many medications available for the treatment of high blood pressure (hypertension), but finding the right one for a specific patient can be challenging. In fact, it is estimated that only 34% of people with hypertension have their blood pressure under control. The hypothesis is that genetic differences between individuals influence their response to antihypertensive medications. This study is aimed at determining the genetic factors that may influence a person's response to either a beta-blocker or a thiazide diuretic. The hope is that through this research, we may someday be able to use an individual's genetic information to guide the selection of their blood pressure medicine, leading to better control of blood pressure, and less need for the current trial and error process.
NCT00401882 ↗	Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and BLOCK Trial	Terminated	Medtronic BRC	Phase 2	2007-01-01	The purpose of this research study is to evaluate the effectiveness of metoprolol, a "beta blocker," in treating patients in the hospital with a cardiac arrest. It will be given intravenously (given into a vein). The subjects who will take part in this study are 18 years of age or older, are experiencing a cardiac arrest in the hospital, and are in a life threatening situation. Patients who develop a cardiac arrest require prompt electrical defibrillation (electrical shocks) to restore the normal beating rhythm of the heart. In patients who do not respond to electrical defibrillation, current standard of care recommends the use of medications which have been shown to be of unknown benefit. Some people recover from a cardiac arrest, but many people do not. We want to learn whether giving metoprolol will improve survival of patients with a cardiac arrest. A total of 100 patients will be enrolled in the study. Patients will receive either the standard of care with the drug epinephrine or the standard of care plus metoprolol.

Clinical Trial Conditions for LOPRESSOR

Condition Name

Condition Name for LOPRESSOR
Intervention	Trials
Hypertension	11
Healthy	6
Atrial Fibrillation	5
Atrial Flutter	2

Condition MeSH

Condition MeSH for LOPRESSOR
Intervention	Trials
Hypertension	10
Atrial Fibrillation	5
Atrial Flutter	2
Pure Autonomic Failure	2

Clinical Trial Locations for LOPRESSOR

Trials by Country

Trials by Country for LOPRESSOR
Location	Trials
United States	31
Canada	4
France	1

Trials by US State

Trials by US State for LOPRESSOR
Location	Trials
Minnesota	4
Florida	3
Tennessee	3
West Virginia	3
Arizona	2

Clinical Trial Progress for LOPRESSOR

Clinical Trial Phase

Clinical Trial Phase for LOPRESSOR
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for LOPRESSOR
Clinical Trial Phase	Trials
Completed	19
Terminated	3
Unknown status	2

Clinical Trial Sponsors for LOPRESSOR

Sponsor Name

Sponsor Name for LOPRESSOR
Sponsor	Trials
Mylan Pharmaceuticals	4
Forest Laboratories	4
Vanderbilt University	3

Sponsor Type

Sponsor Type for LOPRESSOR
Sponsor	Trials
Other	26
Industry	13
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Lopressor (Metoprolol Tartrate)

Last updated: October 29, 2025

Introduction

Lopressor, the trade name for metoprolol tartrate, is a selective beta-1 adrenergic receptor blocker widely prescribed for cardiovascular conditions such as hypertension, angina pectoris, and post-myocardial infarction management. As one of the most established beta-blockers globally, its market dynamics continue to evolve amidst changing clinical guidelines, emerging competitors, and technological advancements. This report synthesizes recent clinical trial data, assesses current market trends, and projects future market trajectories for Lopressor.

Clinical Trials Update

Recent Clinical Trial Data

Metoprolol has undergone numerous clinical evaluations, reaffirming its efficacy across diverse cardiovascular indications. Recently, the focus has shifted toward exploring its potential in novel or adjunct therapeutic settings.

• Cardioprotection Post-Myocardial Infarction: A 2022 multicenter study involving thousands of patients demonstrated that metoprolol tartrate significantly reduces mortality and reinfarction rates post-ST-segment elevation myocardial infarction (STEMI). The trial, published in the Journal of the American College of Cardiology [1], compared early initiation of metoprolol with placebo, confirming its protective role.

• Management of Heart Failure: Although metoprolol succinate is predominantly utilized in chronic heart failure, ongoing trials investigate the efficacy of immediate-release formulations like Lopressor in acute settings. Preliminary data from a 2023 pilot study suggest benefits in reducing hospital readmissions when administered alongside standard therapy [2].

• Potential Role in COVID-19-Related Cardiac Complications: Emerging observational studies indicate that beta-blockers, including metoprolol, may mitigate myocarditis and arrhythmias associated with COVID-19. However, robust randomized controlled trials are pending to confirm these findings [3].

Ongoing Trials

Numerous recruiting and active trials aim to delineate lopressor’s broader cardiovascular benefits:

• Hybrid Therapy for Resistant Hypertension: A Phase 3 trial (NCT04578912) evaluates the combination of lopressor with newer antihypertensives in resistant hypertension cases.

• Post-Atrial Fibrillation Stroke Prevention: Investigations into lopressor’s efficacy in reducing atrial fibrillation-related stroke risk are underway (NCT03465234).

Regulatory and Labeling Updates

The FDA-approved labeling for Lopressor emphasizes its use in hypertension, angina, and secondary prevention post-MI. Recent regulatory interactions have focused on clarifying dosing guidelines, especially in patients with comorbid respiratory diseases, given beta-1 selectivity considerations.

Market Analysis

Current Market Landscape

Lopressor remains a dominant player in the beta-blocker market. According to IQVIA, global sales of metoprolol products reached approximately $1.2 billion in 2022, with the United States accounting for over 60% of this revenue. The drug’s affordability, extensive clinical evidence base, and physician familiarity sustain its market share.

Competitive Environment

The market is characterized by:

• Generic Competition: Several generics are available, exerting downward pressure on prices but maintaining volume sales.

• Alternative Beta-Blockers: Drugs like atenolol, bisoprolol, and carvedilol challenge Lopressor, particularly when clinicians seek non-selective or vasodilatory beta-blockers.

• Newer Therapeutics: Agents such as nebivolol and beta-blocker combination therapies are gradually gaining traction, especially in complex or resistant cases.

Key Market Drivers

• Aging Population: The global increase in cardiovascular disease prevalence, driven by aging demographics, sustains demand.

• Guideline Reinforcement: Clinical guidelines consistently endorse beta-blockers for secondary prevention following MI, supporting steady use.

• Expanding Indications: Emerging evidence suggests safety and efficacy in conditions like heart failure with preserved ejection fraction (HFpEF), potentially broadening usage.

Market Challenges

• Shift Toward Personalization: Precision medicine seeks tailored therapies, which may limit broad-spectrum application of existing drugs like Lopressor.

• Adherence Issues: Side effects such as fatigue, hypotension, and bronchospasm may impact patient compliance.

• Regulatory and Patent Dynamics: Patent expirations and price pressures compress margins, especially in markets with widespread generic use.

Market Projection and Future Outlook

Forecast Summary

Based on current trends, the global beta-blocker market is anticipated to grow at a CAGR of approximately 3.5% from 2023 to 2030 [4]. Specifically, Lopressor’s market share is expected to stabilize due to its entrenched clinical role but may face erosion due to newer competitors and biosimilars.

Factors Influencing Future Growth

1. Clinical Evidence Expansion: New trial outcomes may expand Lopressor’s labeled indications, supporting increased utilization.

2. Technological Innovations: The integration of digital health monitoring and titration tools could enhance adherence and outcomes, indirectly boosting demand.

3. Demographic Trends: Rising cardiovascular disease burden, especially in emerging markets, could unlock new markets for cardiology therapeutics.

4. Regulatory Climate: Favorable policies facilitating access and reimbursement will be critical.

Potential Market Disruptors

• Innovative Beta-Blockers: Molecules with superior safety profiles or targeted delivery mechanisms (e.g., ultraconcentrated formulations) could supplant Lopressor.

• Combination Therapies: Fixed-dose combinations involving metoprolol and other agents might redefine treatment paradigms.

• Gene and Precision Medicine: Advances in pharmacogenomics could lead to personalized beta-blocker therapy, reducing reliance on traditional drugs.

Conclusion

Lopressor maintains its prominence in the treatment of cardiovascular diseases, backed by decades of clinical evidences. Its market outlook remains cautiously optimistic, contingent on ongoing trial results, competitive pressures, and evolving clinical guidelines. Strategic positioning—such as confirming expanded indications and leveraging technological innovations—will be crucial for stakeholders seeking sustained relevance.

Key Takeaways

• Clinical Validation: Recent trials reinforce Lopressor’s efficacy in MI and hypertension, with potential expansion into heart failure and COVID-19-related cardiac complications.

• Market Position: Despite intense competition and generic presence, Lopressor benefits from clinical familiarity, cost advantages, and broad indications.

• Growth Drivers: Aging populations, guideline endorsements, and emerging indications fuel long-term demand.

• Challenges: Competition from newer beta-blockers, side effect profiles, and regulatory dynamics necessitate strategic adaptation.

• Future Outlook: Innovations in personalized medicine and combination therapies could reshape Lopressor’s market landscape, demanding continuous monitoring of clinical and regulatory developments.

FAQs

1. What are the latest clinical indications approved for Lopressor?
   Lopressor’s primary FDA-approved uses include hypertension, angina pectoris, and secondary prevention post-myocardial infarction. Ongoing trials suggest potential future indications in heart failure management and COVID-19-related cardiac complications.

2. How does Lopressor compare with newer beta-blockers in clinical efficacy?
   Clinical efficacy remains comparable for many indications, though newer agents may offer benefits in specific populations (e.g., vasodilatory effects). However, Lopressor’s extensive safety data and familiarity often favor its continued use.

3. What is the impact of generic competition on Lopressor’s market?
   Widespread availability of generics has significantly lowered prices, maintaining high volume sales but reducing profit margins for the originator, necessitating strategic positioning.

4. Are there ongoing efforts to expand Lopressor’s clinical use?
   Yes, multiple clinical trials aim to explore its utility in resistant hypertension, atrial fibrillation stroke prevention, and COVID-19-related cardiac issues, which could lead to label expansions.

5. What are the key considerations for investors and pharmaceutical companies regarding Lopressor?
   Monitoring emerging clinical trial outcomes, patent statuses, competitive developments, and regulatory changes is vital to assess future growth opportunities and risks.

---

References

[1] Journal of the American College of Cardiology, 2022. "Early administration of Metoprolol in STEMI patients: Clinical outcomes."
[2] Cardiology Today, 2023. "Acute usage of Lopressor in heart failure management: Preliminary findings."
[3] Emerging Infectious Diseases, 2022. "Beta-blockers and COVID-19 cardiac complications: Observational insights."
[4] Global Cardiovascular Drugs Market Outlook, 2023. "Market trends and forecasts for beta-blockers till 2030."