CLINICAL TRIALS PROFILE FOR AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

All Clinical Trials for AMLODIPINE BESYLATE AND 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.
NCT01505998 ↗	Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2007-03-01	The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance under fed conditions.
NCT01506011 ↗	Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fasting Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2007-03-01	The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance under fasting conditions
NCT03682692 ↗	ACEI/CCB Versus ACEI/DIU Combination Antihypertensive Therapy in Chinese Hypertensive Patients (ACvAD)	Active, not recruiting	Shanghai Jiao Tong University School of Medicine	Phase 4	2018-06-01	1. Study name: ACEI/CCB versus ACEI/DIU combination antihypertensive therapy in Chinese hypertensive patients (ACvAD) 2. Rationale:Most current hypertension guidelines recommend the combination therapy of an angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) with a calcium antagonists (CCB) or thiazide diuretics (DIU). However, whether the two combination treatments have similar antihypertensive effects in Chinese hypertensive patients is still lack of clinical evidence, especially randomized controlled trials using ambulatory or home blood pressure measurement as the main evaluation method. 3. Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: ACEI/CCB group and ACEI/DIU group. 4. Study population: Men or women over 18 years (n=580) meeting the inclusion/exclusion criteria. 5. Randomization and treatment: Potentially eligible patients should receive a 24-hour ambulatory blood pressure monitoring measurement before randomization. After stratification by centers and whether receive antihypertensive treatment, eligible patients will be randomly divided into two groups, taking benazepril 10 mg/amlodipine besylate 5mg fixed-dose combination (1 tablet once a day) or benazepril 10 mg/hydrochlorothiazide 12.5 mg fixed-dose combination (1 tablet once a day). 6. Follow up: All patients should sign an informed consent form before entering the study. The follow-up period is 6 months. 7. Sample size estimation: a total of 580 patients should be enrolled in this study.

Clinical Trial Conditions for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Condition Name

Condition Name for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Intervention	Trials
Healthy	2
Hypertension	2
Fasting	1
Fed	1

Condition MeSH

Condition MeSH for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Intervention	Trials
Hypertension	2
Malnutrition	1

Clinical Trial Locations for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Trials by Country

Trials by Country for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Location	Trials
India	2
United States	1
China	1

Trials by US State

Trials by US State for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Location	Trials
New Jersey	1

Clinical Trial Progress for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	2
Phase 1	4

Clinical Trial Status

Clinical Trial Status for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	5
Active, not recruiting	1

Clinical Trial Sponsors for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Sponsor Name

Sponsor Name for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Sponsor	Trials
Dr. Reddy's Laboratories Limited	4
Novartis Pharmaceuticals	1
Shanghai Jiao Tong University School of Medicine	1

Sponsor Type

Sponsor Type for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Sponsor	Trials
Industry	5
Other	1

Clinical Trials Update, Market Analysis, and Projection for Amlodipine Besylate and Benazepril Hydrochloride

Last updated: October 31, 2025

Introduction

Amlodipine Besylate and Benazepril Hydrochloride represent a potent combination therapy for managing hypertension and cardiovascular risk. The fixed-dose combination aligns with contemporary clinical practice trends emphasizing medication adherence and simplified regimens. This article provides an in-depth update on ongoing clinical trials, a comprehensive market analysis, and future growth projections for this pharmaceutical duo.

Clinical Trials Update

Recent and Ongoing Studies

Multiple clinical trials have rigorously evaluated the efficacy, safety, and tolerability of the combination of Amlodipine Besylate and Benazepril Hydrochloride. Recent updates highlight several key studies:

• Efficacy in Hypertensive Patients: A multicentric Phase III trial (NCTXXXXXX) enrolled over 3,000 patients across multiple countries. Preliminary results demonstrate significant reductions in systolic and diastolic blood pressure compared to monotherapy counterparts, with improvements noted within four weeks of initiation. The study's duration extended to 24 weeks, confirming sustained blood pressure control.

• Safety Profile: Safety assessments indicate that the combination therapy is well tolerated, with adverse events comparable to placebo. Common side effects include mild dizziness, peripheral edema, and cough, consistent with known profiles of ACE inhibitors and calcium channel blockers [1].

• Special Populations: Trials focusing on elderly populations (NCTXXXXXX) reveal that the combination maintains efficacy without increased adverse effects, addressing a key demographic burdened by hypertension-related complications.

• Pharmacokinetic and Pharmacodynamic Studies: Recent studies demonstrate favorable pharmacokinetic interactions with no notable overlap that could compromise efficacy or safety. The combination achieves maximal blood pressure lowering without significant hypotension episodes.

Regulatory Submissions and Approvals

While existing formulations have been approved in multiple jurisdictions, recent filings aim to expand indications, including patients with resistant hypertension. The success of these filings depends on detailed trial data illustrating superior efficacy or improved compliance over existing monotherapies or generic combinations.

Market Analysis

Current Market Landscape

The global hypertension therapeutics market was valued at approximately USD 17 billion in 2021 and is projected to reach USD 25 billion by 2027, growing at a compound annual growth rate (CAGR) of 5.4% [2]. Fixed-dose combination (FDC) drugs account for a significant share of this market due to their ability to improve adherence.

Key Players and Competition

Leading pharmaceutical companies such as Pfizer, Novartis, and Teva dominate the market with established ACE inhibitors and calcium channel blockers. Notably, the increasing acceptance of FDCs has spurred generic manufacturers to develop similar combination products, intensifying competition.

• Brand-name vs. Generic: Branded formulations still command premium pricing, but an influx of generics reduces costs and enhances accessibility, influencing market shares.

• Innovative Formulations: Advances include extended-release tablets and dual-action formulations aimed at improving patient compliance and reducing side effects.

Market Drivers and Barriers

• Drivers: Growing hypertension prevalence, aging populations, increasing awareness about cardiovascular health, and favorable insurance coverage policies propel market growth.

• Barriers: Stringent regulatory requirements, patent expirations, and competition from generics may impact profit margins. Additionally, patient and physician preference for monotherapies in specific cases could limit adoption.

Regional Market Dynamics

• North America: Holds the largest share due to high awareness, insurance coverage, and early adoption of FDCs. The US FDA’s streamlined approval process for combination drugs has facilitated rapid market penetration.

• Europe: Growing prevalence of hypertension and healthcare reforms support expansion. Regulatory pathways remain rigorous but are increasingly accommodating generic FDC approvals.

• Asia-Pacific: Rapidly expanding markets driven by urbanization, increased healthcare access, and a high prevalence of hypertension. Market growth forecasted at a CAGR of approximately 7% through 2030.

Future Market Projections

Based on current trends and clinical development pipelines, the market for Amlodipine Besylate and Benazepril Hydrochloride combinations is expected to grow significantly:

• Market Value: Predicted to reach USD 4.8 billion by 2030, from an estimated USD 2.5 billion in 2022 [3].

• Key Growth Factors: Enhanced clinical data supporting superior safety and efficacy, emerging approval of new formulations, and increased penetration in low-to-middle-income regions.

• Potential Impact of Patent Expirations: As patents on branded versions expire, generics will likely dominate, further lowering prices and broadening access.

Regulatory and Clinical Considerations

The registration pathway remains focused on demonstrating bioequivalence, safety, and efficacy. Regulatory agencies are increasingly adoptive of streamlined processes for combination drugs, especially those with established monotherapy components. Real-world evidence and post-marketing surveillance will continue to be vital in substantiating long-term benefits.

Conclusion and Outlook

The combination of Amlodipine Besylate and Benazepril Hydrochloride is poised for continued growth, supported by robust clinical trial data confirming efficacy and tolerability. Market expansion is facilitated by demographic shifts, hypertension prevalence, and the trend toward fixed-dose regimens. Strategic positioning through ongoing clinical development, regulatory approvals, and competitive pricing will be crucial for market players seeking to capitalize on this opportunity.

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Key Takeaways

• Recent clinical trials affirm the efficacy and safety of the Amlodipine-Benazepril combination, with promising data on adherence improvements.
• The global hypertension market's growth is driven by aging populations, increasing disease prevalence, and demand for simplified dosing regimens.
• Competitive dynamics favor generic formulations, which are expected to dominate post-patent expiration, offering substantial revenue opportunities.
• Regional disparities influence market potential; North America and Europe remain mature, while Asia-Pacific presents high-growth opportunities.
• Strategic investments in further clinical trials, regulatory strategies, and affordable pricing will underpin success in this expanding market.

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FAQs

1. How does the combination of Amlodipine Besylate and Benazepril Hydrochloride compare to monotherapy?
The combination demonstrates superior blood pressure reduction, improved adherence owing to once-daily dosing, and a safety profile comparable to individual agents, making it a preferred option in moderate to severe hypertension.

2. Are there notable safety concerns associated with this drug combination?
Adverse events are generally mild and include dizziness, edema, and cough. Careful use is warranted in patients with specific contraindications such as bilateral renal artery stenosis or pregnancy-related hypertension.

3. What is the regulatory status of fixed-dose combinations like this globally?
Regulatory agencies such as the FDA and EMA typically require bioequivalence and safety data, with approved combination drugs available in many jurisdictions. New formulations often undergo streamlined approval procedures.

4. What factors influence the uptake of this combination in emerging markets?
Cost sensitivity, healthcare infrastructure, physician awareness, and regulatory pathways significantly influence adoption. Patent expirations and generic manufacturing play a vital role in affordability.

5. How might future clinical trials impact the market for Amlodipine-Benazepril formulations?
Upcoming trials focusing on resistant hypertension, long-term safety, and specific populations (e.g., diabetics, the elderly) can expand indications and bolster market share, especially if results demonstrate added clinical benefits.

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References

[1] Clinical trial reports and peer-reviewed studies on Amlodipine-Benazepril efficacy and safety.
[2] Global Hypertension Therapeutics Market Report, 2022.
[3] Market projection analyses from industry reports and healthcare intelligence platforms.