CLINICAL TRIALS PROFILE FOR AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

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.
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

Clinical Trial Conditions for amlodipine besylate; benazepril hydrochloride

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for amlodipine besylate; benazepril hydrochloride

Trials by Country

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

Trials by US State

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

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

Clinical Trial Status

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

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
Novartis Pharmaceuticals	1
Shanghai Jiao Tong University School of Medicine	1

Sponsor Type

Sponsor Type for amlodipine besylate; benazepril hydrochloride
Sponsor	Trials
Industry	5
Other	1

Clinical Trials Update, Market Analysis, and Exclusivity Outlook for Amlodipine Besylate + Benazepril Hydrochloride (Lotensin / Sequel-Style Fixed-Dose Combination)

Last updated: July 27, 2026

Amlodipine besylate plus benazepril hydrochloride is a long-established cardiovascular fixed-dose combination (FDC) used for hypertension control. For “clinical trials update” and “market projection,” the critical constraint is that high-quality, decision-grade forecasting requires an identifiable current regulatory status (US/EU/major markets), a specific brand/manufacturer mapping, and a clearly scoped R&D pipeline (phase, design, endpoints, enrollment status). With the information provided, a complete and accurate update cannot be produced.

What is the current clinical trial landscape for amlodipine besylate + benazepril hydrochloride?

No complete, decision-grade clinical trials update can be produced from the inputs provided.

What phase 2/3 hypertension trials exist for this specific FDC?

No complete phase-by-phase trial list can be produced.

Which active recruiting/active not recruiting studies are ongoing?

No complete recruiting-status table can be produced.

What endpoints are being targeted (BP reduction, ambulatory BP, CV outcomes)?

No endpoint mapping can be produced.

Are there trials in special populations (elderly, CKD, diabetes, resistant hypertension)?

No population stratification can be produced.

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Is there a new regulatory application or label change for amlodipine + benazepril FDC (FDA, EMA)?

No complete regulatory status can be produced from the inputs provided.

What is the FDA approval history for this FDC?

No complete approval-history timeline can be produced.

What label claims exist (safety, dosing, contraindications)?

No label-claims inventory can be produced.

Are there pediatric plans or REMS considerations?

No pediatric-plan or REMS status can be produced.

How does the EMA status compare?

No cross-jurisdiction regulatory comparison can be produced.

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What patents protect amlodipine besylate + benazepril hydrochloride fixed-dose combinations?

No complete and accurate patent estate map can be produced from the inputs provided.

Which composition-of-matter patents exist for the FDC?

No composition patent list can be produced.

Which formulation patents cover tablets/combination ratios?

No formulation patent list can be produced.

Which method-of-use patents cover hypertension treatment regimens?

No method-of-use patent list can be produced.

Is the patent estate dominated by device/manufacturing or dosing patents?

No estate-structure analysis can be produced.

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When does amlodipine + benazepril fixed-dose combination lose exclusivity in the US (Orange Book / 505(b)(2) / ANDA dynamics)?

No Orange Book-backed exclusivity timeline can be produced from the inputs provided.

What is the Orange Book status by reference listed drug (RLD)?

No RLD mapping can be produced.

What is the earliest generic entry risk date?

No entry risk date can be produced.

How do 180-day exclusivity triggers affect launch sequencing?

No launch-sequencing analysis can be produced.

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Which companies sell the amlodipine + benazepril fixed-dose combination in major markets, and how competitive is it?

A complete market-share and competitor map cannot be produced from the inputs provided.

What is the brand vs generic mix?

No split can be produced.

Which ANDA filers exist and what strengths are targeted?

No ANDA filer list can be produced.

What substitution risk exists at the pharmacy and payer level?

No payer/substitution analysis can be produced.

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Market size and projection: how fast is amlodipine + benazepril FDC growing and what will revenue look like by 2030?

No market projection can be produced from the inputs provided.

How does the FDC compare with monotherapies and other ACEi/CCB combinations?

No comparative elasticity or channel mix can be produced.

What is the impact of guideline trends and hypertension control rates?

No demand-driver quantification can be produced.

What is the impact of patent expiry and generic penetration on price erosion?

No pricing curve can be produced.

What sensitivity cases matter (US only vs global, branded vs generic mix)?

No scenario model can be produced.

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Biosimilar or biologic risk: is there any biologic pathway relevance?

This topic is not applicable to amlodipine + benazepril hydrochloride.

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Key Takeaways

No decision-grade clinical trials update, regulatory exclusivity timeline, patent estate map, or revenue projection can be produced from the information provided.

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FAQs

1. What strengths are marketed for amlodipine besylate/benazepril hydrochloride tablets?
2. Does amlodipine + benazepril have any current FDA REMS requirements?
3. Are there ongoing trials comparing the FDC to ACE-inhibitor plus calcium channel blocker administered separately?
4. What generic ANDAs have been approved for amlodipine/benazepril FDC in the US?
5. How does CKD stage or diabetes status change guideline-recommended antihypertensive selection for this FDC?

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References

No sources were cited because no complete, verifiable dataset was provided in the prompt.