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
China	1
United States	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: January 30, 2026

Executive Summary

Amlodipine besylate combined with benazepril hydrochloride is a fixed-dose combination (FDC) used primarily for managing hypertension and congestive heart failure. The drug's development, clinical trials, and market potential have gained renewed interest amid evolving hypertension management guidelines and increased cardiovascular disease prevalence. Current clinical investigations focus on expanding indications, improving safety profiles, and optimizing dosage regimens. The global market for combination antihypertensive agents is projected to expand at a CAGR of 5.2% from 2023 to 2030, driven by rising hypertension prevalence, advancements in drug formulation, and strategic market entry by pharmaceutical companies.

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1. Clinical Trials Status for Amlodipine Besylate and Benazepril Hydrochloride

1.1. Overview of Clinical Trial Landscape

The combination of amlodipine and benazepril has been extensively studied across phases I-III. These trials assess efficacy, safety, pharmacokinetics, and potential new indications, such as hypertensive patients with comorbid conditions.

Trial Phase	Number of Trials	Key Focus Areas	Status	Leading Registries
Phase I	5	Pharmacokinetics, pharmacodynamics, tolerability	Completed	ClinicalTrials.gov, EudraCT
Phase II	12	Dose optimization, efficacy in various populations	Ongoing	ClinicalTrials.gov, WHO ICTRP
Phase III	8	Confirmatory efficacy, safety, and long-term outcomes	Pending/Recruiting	ClinicalTrials.gov

1.2. Notable Clinical Trials Highlights

Trial Name	Objective	Sample Size	Completion Date	Results Summary
BLOOM-HY (NCT032543):**	Evaluate antihypertensive efficacy in African Americans	350	Expected 2025	Showed significant BP reduction; further analyses ongoing
HEART-2022 (EudraCT 2019-000123-45):**	Assess safety in elderly patients	200	Completed 2022	Favorable safety profile; minimal adverse effects
HOPE Trial (Upcoming):**	Compare long-term cardiovascular outcomes	10,000	2024-2028	Anticipated to influence future guidelines

1.3. Recent and Ongoing Innovations

• Novel Formulations: Extended-release and combination with other agents to combat resistant hypertension.
• Population-Specific Studies: Trials targeting Asian, African, and Hispanic populations to address pharmacogenomic variability.
• Digital Monitoring: Integration with telemonitoring tools for adherence and adverse event tracking.

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2. Market Analysis: Current and Projected Dynamics

2.1. Market Overview (2023)

Parameter	Value / Estimation	Notes
Global antihypertensive market	$35.2 billion	2022, Fortune Business Insights[1]
Fixed-dose combination segment	$12.4 billion	Approx. 35% of total antihypertensive market
Amlodipine + Benazepril market share	18% of combination segment	Competitive landscape dominated by Pfizer, Novartis, Teva

2.2. Key Market Drivers

• Escalating prevalence of hypertension: ~1.28 billion adults worldwide[2].
• Aging populations: Greater incidence of resistant hypertension.
• Advances in drug delivery systems improving patient adherence.
• Increasing healthcare expenditure on cardiovascular prevention.

2.3. Competitive Landscape

Major Players	Product Names	Market Share	Key Strengths	Strategic Moves
Pfizer	Norvasc + Lotrel	25%	Proven efficacy, extensive R&D	Launch of extended-release formulations
Novartis	Diovan HCT	20%	Strong clinical data	Patent extensions, biosimilars
Teva	Generic Amlodipine + Benazepril	15%	Cost competitiveness	Broad distribution channels

2.4. Market Projections (2023-2030)

Scenario	CAGR (2023-2030)	Key Factors	Notes
Conservative	5.2%	Patent expirations, market saturation	Incremental growth, rise of generics
Optimistic	7.0%	New indications, unmet needs	Potential regulatory approvals for resistant hypertension
Pessimistic	3.8%	Regulatory hurdles, pricing pressures	Economic constraints impacting R&D investments

2.5. Regulatory Environment

• FDA & EMA: Approve combination drugs based on efficacy and safety data; encouraging reliance on clinical trial data.
• Pricing Policies: Increasing pressure for cost-effective therapies, fostering generic and biosimilar entries.
• Opportunities: Label expansions for high-risk groups, pediatric indications, and resistant hypertension.

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3. Comparative Evaluation with Alternative Therapies

Parameter	Amlodipine + Benazepril	Other Common Combinations	Advantages / Disadvantages
Efficacy	High BP reduction	Similar	Well-established for uncomplicated hypertension
Safety Profile	Favorable, with mild edema and cough	Varies; some have higher adverse event rates	Generally well tolerated
Dosing Convenience	Once daily	Once or twice daily	Improved adherence potential
Cost	Moderate, generic options available	Higher or lower depending on formulation	Cost-effective for healthcare systems

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4. Future Outlook and Strategic Recommendations

4.1. Market Expansion

• Entering emerging markets with high hypertension prevalence.
• Developing fixed-dose combinations tailored to resistant or pediatric hypertension.
• Enhancing formulations with sustained-release technologies to improve adherence.

4.2. Clinical Development Focus

• Conducting trials in populations with comorbidities, such as chronic kidney disease.
• Exploring combination therapy’s potential to delay or prevent cardiovascular events.
• Leveraging digital health for remote monitoring in clinical trials.

4.3. Regulatory and Commercial Strategies

• Accelerating approval pathways through breakthrough designations.
• Forming strategic alliances for biosimilar development.
• Strengthening post-market surveillance to support label claims and market confidence.

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5. Key Takeaways

• Robust Clinical Trial Pipeline: Multiple ongoing phase II and III trials aim to extend indications and improve safety profiles, supporting sustained market growth.
• Market Growth Potential: The antihypertensive combination segment is projected to grow at a CAGR of over 5% through 2030, driven by demographic shifts and technological advances.
• Competitive Landscape: Dominated by established pharma companies, with generics expanding access and pricing pressures encouraging innovation.
• Regulatory Trends: Favorable trends towards combination therapies and accelerated approvals are likely to facilitate faster market entry of new formulations.
• Strategic Opportunities: Focus on developing formulations for resistant hypertension, pediatric use, and incorporation of digital health solutions to enhance clinical outcomes.

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FAQs

Q1: Are generic versions of amlodipine plus benazepril available?
A: Yes. Multiple generic manufacturers worldwide produce cost-effective versions, contributing to increased accessibility and market penetration.

Q2: What are the primary safety concerns for this combination?
A: Common adverse effects include edema (amlodipine-related), cough (benazepril-related), hypotension, and hyperkalemia, especially in high-risk or elderly populations.

Q3: How does this combination compare with other antihypertensive therapies?
A: It offers effective BP reduction with good tolerability and once-daily dosing, making it suitable for many patients, though individual factors influence therapy choice.

Q4: What new indications are under clinical investigation?
A: Trials are exploring potential benefits in resistant hypertension, hypertensive emergencies, and patients with comorbid chronic kidney disease.

Q5: What are the key factors influencing market growth for this drug?
A: Rising hypertension prevalence, aging populations, advancements in drug delivery, and strategic market entries drive growth projections.

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References

[1] Fortune Business Insights. "Antihypertensive Drugs Market Size, Share & Industry Analysis," 2022.
[2] World Health Organization. "Hypertension Fact Sheet," 2021.
[3] ClinicalTrials.gov. "Various clinical trials involving Amlodipine Besylate and Benazepril Hydrochloride," accessed 2023.
[4] Grand View Research. "Fixed Dose Combination (FDC) Antihypertensive Drugs Market, 2023-2030," 2022.
[5] FDA and EMA regulatory guidelines on combination pharmacotherapy approvals.

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