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Last Updated: January 3, 2025

CLINICAL TRIALS PROFILE FOR AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE


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All Clinical Trials for amlodipine besylate; benazepril hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00136851 ↗ Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension Completed Novartis Pharmaceuticals Phase 4 2004-12-01 This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.
NCT01155895 ↗ Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 2004-03-01 The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under fasting conditions.
NCT01155908 ↗ Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 2005-04-01 The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under non-fasting (fed) conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for amlodipine besylate; benazepril hydrochloride

Condition Name

Condition Name for amlodipine besylate; benazepril hydrochloride
Intervention Trials
Healthy 2
Hypertension 2
Fed 1
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Condition MeSH

Condition MeSH for amlodipine besylate; benazepril hydrochloride
Intervention Trials
Hypertension 2
Malnutrition 1
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Clinical Trial Locations for amlodipine besylate; benazepril hydrochloride

Trials by Country

Trials by Country for amlodipine besylate; benazepril hydrochloride
Location Trials
India 2
China 1
United States 1
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Trials by US State

Trials by US State for amlodipine besylate; benazepril hydrochloride
Location Trials
New Jersey 1
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Clinical Trial Progress for amlodipine besylate; benazepril hydrochloride

Clinical Trial Phase

Clinical Trial Phase for amlodipine besylate; benazepril hydrochloride
Clinical Trial Phase Trials
Phase 4 2
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for amlodipine besylate; benazepril hydrochloride
Clinical Trial Phase Trials
Completed 5
Active, not recruiting 1
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Clinical Trial Sponsors for amlodipine besylate; benazepril hydrochloride

Sponsor Name

Sponsor Name for amlodipine besylate; benazepril hydrochloride
Sponsor Trials
Dr. Reddy's Laboratories Limited 4
Shanghai Jiao Tong University School of Medicine 1
Novartis Pharmaceuticals 1
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Sponsor Type

Sponsor Type for amlodipine besylate; benazepril hydrochloride
Sponsor Trials
Industry 5
Other 1
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Amlodipine besylate; benazepril hydrochloride Market Analysis and Financial Projection

Amlodipine Besylate and Benazepril Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Amlodipine besylate and benazepril hydrochloride are two medications commonly used in the management of hypertension and cardiovascular diseases. This article delves into the clinical trials, market analysis, and projections for these drugs, providing a comprehensive overview of their efficacy, market dynamics, and future outlook.

Clinical Trials: Efficacy and Safety

Combination Therapy vs Monotherapy

Several clinical trials have evaluated the efficacy and safety of combining amlodipine besylate with benazepril hydrochloride. A double-blind study compared the effects of high-dose combinations of amlodipine besylate (5 mg and 10 mg) and benazepril hydrochloride (40 mg) to benazepril hydrochloride (40 mg) alone in patients not adequately controlled with benazepril monotherapy. The results showed that the combination therapy was more effective in reducing blood pressure compared to monotherapy[1].

Another study, a randomized, double-blind trial, compared the effects of amlodipine besylate/benazepril HCl combination treatment versus amlodipine besylate monotherapy on endothelial function and blood pressure. The study found that both treatments improved endothelial function, but the combination therapy showed numerically larger improvements, although the differences were not statistically significant[4].

Patient Outcomes and Compliance

These studies highlight the benefits of combination therapy in managing hypertension. Combination therapies like amlodipine besylate and benazepril hydrochloride enhance patient compliance by reducing the pill burden and improving efficacy, which is crucial for long-term disease management[3].

Market Analysis

Global Market Size and Growth

The global amlodipine besylate market has been experiencing steady growth, driven by the rising prevalence of hypertension and cardiovascular diseases. As of 2023, the market size was recorded at USD 1,867.0 million, with projections indicating it will reach USD 1,933.0 million in 2024 and USD 2,539.5 million by 2031, growing at a CAGR of 3.98% from 2024 to 2031[2][3].

Regional Analysis

North America dominates the global amlodipine besylate market, with a market share of around 34.56% in 2023. This dominance is attributed to the high prevalence of hypertension and cardiovascular diseases, advanced healthcare infrastructure, high healthcare spending, and widespread insurance coverage in the region[2][5].

The Asia Pacific region is also poised for rapid growth, registering a CAGR of 5.09% during the forecast period. This growth is driven by increasing awareness about cardiovascular health, rising prevalence of hypertension, and government initiatives promoting preventive healthcare and early treatment[2].

Sales Channels and Distribution

The market is segmented by sales channels, including hospital pharmacies, drug stores & pharmacies, online retails, and others. The online retail segment is expected to witness significant growth at a CAGR of 4.67% from 2024 to 2031, driven by the convenience and accessibility offered by e-commerce platforms[2][3].

Competitive Landscape

The amlodipine besylate market features a robust competitive landscape with numerous global and regional pharmaceutical companies, including Pfizer, Mylan, Reddy’s Laboratories, Apotex, Teva Pharmaceutical, and others. These companies are competing for market share through improved formulations, combination therapies, and patient-centric care initiatives[2][3].

Market Projections and Forecast

Driving Factors for Growth

The growth of the amlodipine besylate market is driven by several key factors:

  • Rising Prevalence of Hypertension and Cardiovascular Diseases: According to the WHO, approximately 1.28 million adults aged 30-79 in low and middle-income countries suffer from hypertension, with many remaining unaware of their condition[2][3].
  • Increasing Adoption of Combination Therapies: Combination therapies enhance patient compliance and accessibility, contributing to sustained demand for these medications[2][3].
  • Advancements in Pharmaceutical Formulations: Improved formulations, such as extended-release versions, help in better disease management and patient adherence[2][3].

Pharmacoeconomic Impact

A study on the pharmacoeconomic impact of amlodipine besylate in Italy highlighted its cost-effectiveness in treating coronary artery disease (CAD). The study showed that adding amlodipine besylate to standard care reduced major vascular events and revascularization procedures, resulting in significant savings in hospital expenditures[2].

Challenges and Opportunities

Despite the growth, the market faces challenges such as fierce competition from generic drugs, leading to price erosion and reduced profit margins for manufacturers. To overcome this, pharmaceutical companies must focus on differentiating their products through improved formulations and combination therapies[2][3].

Digital Health and Patient-Centric Care

Integration of Digital Health Technologies

The growing focus on patient-centric care is shaping the amlodipine besylate market dynamics. Digital health technologies, such as mobile health apps and telemedicine, are being integrated into hypertension management, allowing for better monitoring and adherence to treatment. This trend emphasizes the importance of patient engagement and convenience, leading to innovations aimed at enhancing the overall effectiveness and accessibility of hypertension therapies[3].

Key Takeaways

  • Growing Market Size: The global amlodipine besylate market is projected to reach USD 2,539.5 million by 2031.
  • Regional Dominance: North America and the Asia Pacific region are key markets, with the latter experiencing rapid growth.
  • Combination Therapies: Combination therapies with benazepril hydrochloride are more effective in managing hypertension.
  • Digital Health: Integration of digital health technologies is enhancing patient care and adherence.
  • Competitive Landscape: The market is characterized by a robust competitive landscape with numerous pharmaceutical companies.

FAQs

Q1: What is the current market size of the amlodipine besylate market?

The global amlodipine besylate market size was recorded at USD 1,867.0 million in 2023[2][3].

Q2: What are the primary drivers of the amlodipine besylate market growth?

The primary drivers include the rising prevalence of hypertension and cardiovascular diseases, increasing adoption of combination therapies, and advancements in pharmaceutical formulations[2][3].

Q3: Which region dominates the global amlodipine besylate market?

North America dominates the global amlodipine besylate market, with a market share of around 34.56% in 2023[2][5].

Q4: How is the online retail segment impacting the amlodipine besylate market?

The online retail segment is expected to witness significant growth at a CAGR of 4.67% from 2024 to 2031, driven by the convenience and accessibility offered by e-commerce platforms[2][3].

Q5: What are the challenges faced by the amlodipine besylate market?

The market faces significant competition from generic drugs, leading to price erosion and reduced profit margins for manufacturers. To overcome this, pharmaceutical companies must focus on differentiating their products through improved formulations and combination therapies[2][3].

Sources

  1. Amlodipine/benazepril combination therapy for hypertensive patients - Academic.oup.com
  2. Generic AMLODIPINE BESYLATE INN equivalents, drug patent - Drugpatentwatch.com
  3. Amlodipine Besylate Market Size, Share, Growth & Industry Analysis - Kingsresearch.com
  4. A randomized, double-blind trial comparing the effects of amlodipine besylate/benazepril HCl vs amlodipine - Pure.johnshopkins.edu
  5. Amlodipine Market Size, Share, Growth, Current Analysis, 2034 - Transparencymarketresearch.com

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