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Last Updated: January 21, 2025

CLINICAL TRIALS PROFILE FOR METOPROLOL SUCCINATE


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All Clinical Trials for Metoprolol Succinate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00077948 ↗ Enoximone Plus Extended-Release Metoprolol Succinate in Subjects With Advanced Chronic Heart Failure Terminated AstraZeneca Phase 3 2003-07-01 Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words, they have difficulty tolerating beta-blocker medications. The purpose of this study is to determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication.
NCT00077948 ↗ Enoximone Plus Extended-Release Metoprolol Succinate in Subjects With Advanced Chronic Heart Failure Terminated Gilead Sciences Phase 3 2003-07-01 Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words, they have difficulty tolerating beta-blocker medications. The purpose of this study is to determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication.
NCT00123903 ↗ COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria Terminated GlaxoSmithKline Phase 3 2005-07-01 This study was designed to determine whether COREG MR is more effective than TOPROL-XL in reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood pressure and microalbuminuria.
NCT00166400 ↗ A Randomized Clinical Trial of Metoprolol in Participants With Mitral Regurgitation. Completed AstraZeneca Phase 4 2004-07-01 Mitral valve regurgitation (leakage of the mitral valve of the heart) is frequent and currently there is no specific medical therapy. Mitral regurgitation is a slowly progressive disease that frequently requires surgical treatment. This randomized clinical trial will use Metoprolol, a common beta-blocker medication, to determine if medical treatment impacts mitral valve disease progression.
NCT00166400 ↗ A Randomized Clinical Trial of Metoprolol in Participants With Mitral Regurgitation. Completed Mayo Clinic Phase 4 2004-07-01 Mitral valve regurgitation (leakage of the mitral valve of the heart) is frequent and currently there is no specific medical therapy. Mitral regurgitation is a slowly progressive disease that frequently requires surgical treatment. This randomized clinical trial will use Metoprolol, a common beta-blocker medication, to determine if medical treatment impacts mitral valve disease progression.
NCT00255502 ↗ 307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects Completed AstraZeneca Phase 3 2002-07-01 This was a 52-week, multicenter, open-label study to determine the safety, tolerability and pharmacokinetics of TOPROL-XL (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in hypertensive pediatric subjects. The study population included school age children (age 6 to 12 years < Tanner Stage 3) and adolescents (> 12 years old or > Tanner Stage 3 to 16 years old) of both genders. Because response to some therapies in adult hypertension appears to be different in black and non-black populations, the recruitment will have a mixture of black and non-black subjects. Pharmacokinetic measurements were performed on a subset of patients. Thirty subjects (15 subjects each in the 6 to 12 year age group and the 13 to 16 year age group) had a series of blood samples drawn. All subjects had a trough plasma level taken 24 hours after the last dose of open-label metoprolol CR/XL (Visit 18) with the exception of those subjects who completed Protocol 307B (16 week open-label treatment).
NCT00255528 ↗ Dose Ranging, Safety and Tolerability of TOPROL-XL® Extended-Release Tablets in Hypertensive Pediatric Subjects Completed AstraZeneca Phase 3 2002-07-01 This was a 4-week, multicenter, double-blind, placebo-controlled, randomized, parallel-group study to determine the antihypertensive dose range, efficacy, safety and tolerability of TOPROL-XL ® (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in hypertensive pediatric subjects. The study population included school age children (age 6 to < Tanner Stage 3) and adolescents (> Tanner Stage 3 to age 16) of both genders. No more than 50% of the randomized subjects could be adolescents (> Tanner Stage 3 to 16 years old). Since response to some therapies in adult hypertension appears to be different in black and non-black populations, recruitment was aimed at a mixture of black and non-black children. The design included a 1-week screening period (for treatment naive subjects), a 1-week single-blind placebo run-in period, and a 4-week double-blind treatment period. Eligible subjects were randomized to the double-blind period with a once daily oral dose of metoprolol CR/XL to one of three target doses: 0.2, 1.0 and 2.0 mg/kg, or placebo. Dosing was weight adjusted. The dose range for this study was 12.5 to 200 mg daily. Subjects were closely monitored and evaluated at the end of Weeks 1, 2, 3 and 4 during the double-blind treatment period.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Metoprolol Succinate

Condition Name

Condition Name for Metoprolol Succinate
Intervention Trials
Hypertension 21
Heart Failure 7
Heart Failure With Preserved Ejection Fraction 3
Healthy 3
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Condition MeSH

Condition MeSH for Metoprolol Succinate
Intervention Trials
Hypertension 23
Heart Failure 12
Cardiomyopathies 6
Hypertrophy 2
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Clinical Trial Locations for Metoprolol Succinate

Trials by Country

Trials by Country for Metoprolol Succinate
Location Trials
United States 161
China 28
Canada 17
India 5
Denmark 3
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Trials by US State

Trials by US State for Metoprolol Succinate
Location Trials
New York 11
Pennsylvania 9
Utah 8
Florida 7
California 7
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Clinical Trial Progress for Metoprolol Succinate

Clinical Trial Phase

Clinical Trial Phase for Metoprolol Succinate
Clinical Trial Phase Trials
Phase 4 25
Phase 3 14
Phase 2/Phase 3 1
[disabled in preview] 16
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Clinical Trial Status

Clinical Trial Status for Metoprolol Succinate
Clinical Trial Phase Trials
Completed 34
Terminated 9
Not yet recruiting 6
[disabled in preview] 9
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Clinical Trial Sponsors for Metoprolol Succinate

Sponsor Name

Sponsor Name for Metoprolol Succinate
Sponsor Trials
AstraZeneca 10
Forest Laboratories 7
GlaxoSmithKline 5
[disabled in preview] 11
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Sponsor Type

Sponsor Type for Metoprolol Succinate
Sponsor Trials
Other 74
Industry 41
NIH 3
[disabled in preview] 3
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Metoprolol Succinate: Clinical Trials, Market Analysis, and Projections

Introduction

Metoprolol succinate, a beta-blocker, is widely used in the management of various cardiovascular conditions, including hypertension, heart failure, and hypertrophic obstructive cardiomyopathy (HOCM). This article delves into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials: TEMPO and Other Studies

TEMPO Trial

The TEMPO trial, a randomized, double-blind, placebo-controlled crossover study, evaluated the efficacy of metoprolol succinate in patients with HOCM. The trial involved 58 patients who were randomized to either metoprolol succinate or placebo for 2 weeks, followed by a crossover to the opposite treatment for another 2 weeks. Key findings included:

  • Reduced LVOT Obstruction: Metoprolol succinate significantly reduced left ventricular outflow tract (LVOT) gradients at rest, during peak exercise, and post-exercise compared to placebo[1][5].
  • Symptom Relief and Quality of Life: Patients on metoprolol succinate experienced improved symptoms and quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score[1][5].
  • Heart Rate and Exercise Capacity: Metoprolol succinate lowered heart rates at peak exercise but did not improve exercise capacity[1].

MERIT-HF Trial

The Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF) was a large-scale study involving 3991 patients with heart failure. This trial demonstrated that metoprolol CR/XL (a controlled-release/extended-release formulation of metoprolol succinate) reduced all-cause mortality and hospitalizations. The study highlighted the importance of gradual titration of the drug to avoid clinical deterioration, especially in patients with severe heart failure[3].

Market Analysis

Global Market Size and Growth

The global metoprolol succinate market is expected to expand significantly over the next few years. According to Cognitive Market Research, the market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.70% from 2024 to 2031, driven by the increasing prevalence of cardiovascular diseases[2].

Regional Market Share

  • North America: Holds more than 40% of the global revenue, with a market size expected to grow at a CAGR of 2.9% from 2024 to 2031[2].
  • Europe: Accounts for over 30% of the global revenue, with a CAGR of 3.2% from 2024 to 2031[2].
  • Asia Pacific: Expected to grow at a CAGR of 6.7% from 2024 to 2031, driven by the increasing demand for cardiovascular treatments[2].

Dosage and Formulations

The 25mg and 50mg formulations of metoprolol succinate are gaining traction. The 25mg formulation is preferred for its effectiveness in handling cardiovascular conditions with lower dosage options, while the 50mg formulation is popular for its effective control of mild dosage changes[2].

Application and End-Use

  • Hospitals: The largest market segment, driven by the increasing community of hospitals and the adoption of standardized treatment protocols for cardiovascular care[2].
  • Clinics: A rapidly growing sector, especially those specializing in cardiovascular care, which are increasingly aware of outpatient control of conditions like hypertension and heart failure[2].
  • Adults: The dominant demographic, with the growing adult population significantly impacting the market due to the increasing prevalence of cardiovascular diseases[2].

Projections and Future Outlook

Market Growth Drivers

  • Increasing Prevalence of Cardiovascular Diseases: The rising incidence of hypertension, heart failure, and other cardiovascular conditions is expected to boost the demand for metoprolol succinate[2].
  • Advancements in Healthcare: Improved diagnostic techniques and treatment protocols will further drive the adoption of metoprolol succinate in clinical settings[2].

Challenges and Opportunities

  • Raw Material Costs and Production Fluctuations: Factors such as raw material costs, production fluctuations, and geopolitical influences can impact the pricing and availability of metoprolol succinate[4].
  • Combination Therapy: The trend towards combination therapy, where metoprolol succinate is used in conjunction with other medications, is expected to expand its market reach[2].

Key Takeaways

  • Clinical Efficacy: Metoprolol succinate has been shown to be effective in reducing LVOT obstruction, providing symptom relief, and improving quality of life in patients with HOCM and other cardiovascular conditions.
  • Market Growth: The global metoprolol succinate market is projected to grow significantly, driven by the increasing prevalence of cardiovascular diseases and advancements in healthcare.
  • Regional Variations: North America, Europe, and Asia Pacific are key regions driving the market growth, with varying CAGRs and market shares.
  • Dosage and Formulations: The 25mg and 50mg formulations are gaining traction due to their effectiveness and patient preference.

FAQs

What is the primary use of metoprolol succinate in clinical settings?

Metoprolol succinate is primarily used to treat conditions such as hypertension, heart failure, and hypertrophic obstructive cardiomyopathy (HOCM).

What were the key findings of the TEMPO trial?

The TEMPO trial showed that metoprolol succinate reduced LVOT obstruction, provided symptom relief, and improved quality of life in patients with HOCM.

How is the global metoprolol succinate market expected to grow?

The global metoprolol succinate market is expected to grow at a CAGR of 4.70% from 2024 to 2031, driven by the increasing prevalence of cardiovascular diseases.

Which regions dominate the metoprolol succinate market?

North America, Europe, and Asia Pacific are the dominant regions, with North America holding over 40% of the global revenue.

What are the most common dosages of metoprolol succinate?

The 25mg and 50mg formulations are the most common and are gaining traction due to their effectiveness and patient preference.

Sources

  1. The Effect of Metoprolol in Patients With Hypertrophic Obstructive Cardiomyopathy - TEMPO. American College of Cardiology.
  2. Metoprolol Succinate Market Report 2024 (Global Edition). Cognitive Market Research.
  3. Tolerability of β-Blocker Initiation and Titration in the Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF). American Heart Association Journals.
  4. Exploring Latest Metoprolol Succinate Prices, Price Trend. OpenPR.
  5. Randomized Trial of Metoprolol in Patients With Obstructive Hypertrophic Cardiomyopathy. Journal of the American College of Cardiology.

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