CLINICAL TRIALS PROFILE FOR TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

All Clinical Trials for trandolapril; verapamil hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00133692 ↗	INVEST: INternational VErapamil SR Trandolapril STudy	Completed	Abbott	Phase 4	1997-09-01	Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is important to keep it as normal as possible. There are several different ways to control blood pressure and to prevent or limit the development of heart disease due to high blood pressure. The purpose of this study is to compare two treatments to see how well they work and the difference in their side effects. One treatment includes the use of a calcium antagonist drug (Isoptin sustained release [SR] or Verapamil SR). The other treatment excludes the calcium antagonist and may include a non-calcium antagonist drug called a beta blocker (Tenormin or Atenolol). Both treatments may also include medication called angiotensin converting enzyme (ACE) inhibitors and water pills. None of the drugs in this study are experimental, they are all approved by the Food and Drug Administration (FDA).
NCT00133692 ↗	INVEST: INternational VErapamil SR Trandolapril STudy	Completed	University of Florida	Phase 4	1997-09-01	Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is important to keep it as normal as possible. There are several different ways to control blood pressure and to prevent or limit the development of heart disease due to high blood pressure. The purpose of this study is to compare two treatments to see how well they work and the difference in their side effects. One treatment includes the use of a calcium antagonist drug (Isoptin sustained release [SR] or Verapamil SR). The other treatment excludes the calcium antagonist and may include a non-calcium antagonist drug called a beta blocker (Tenormin or Atenolol). Both treatments may also include medication called angiotensin converting enzyme (ACE) inhibitors and water pills. None of the drugs in this study are experimental, they are all approved by the Food and Drug Administration (FDA).
NCT00234871 ↗	Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)	Completed	Abbott	Phase 4	2004-01-01	The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy
NCT00497666 ↗	Association Between Rosiglitazone Use and Clinical Course of Diabetic Nephropathy: Population-Based Study	Unknown status	Assaf-Harofeh Medical Center		2007-08-01	Recent data show that Rosiglitazone treatment can reduce proteinuria in diabetic patients. However, currently there are no trials that examine the effects of Rosiglitazone on kidney disease progression, that is, doubling of serum creatinine or time to onset of end-stage renal disease, in patients with diabetic nephropathy. We decided to study retrospectively the possible association between rosiglitazone use and clinical course of diabetic nephropathy, including rate of deterioration of renal function, appearance and progression of microalbuminuria/proteinuria, survival and acceptance to renal replacement therapy.
NCT00503152 ↗	Preventing Microalbuminuria in Type 2 Diabetes	Completed	Agenzia Italiana del Farmaco	Phase 3	2007-05-01	In people with type 2 diabetes, microalbuminuria is a strong, independent risk factor for diabetic nephropathy and cardiovascular morbidity and mortality. ACE inhibitor therapy decreased the risk of microalbuminuria in hypertensive subjects with type 2 diabetes and normoalbuminuria by about 40%. Available data suggest that angiotensin II receptor blockers (ARBs) might have a similar renoprotective effect and that this effect might be increased by combined ACE inhibitor therapy. The study will evaluate the effects, at similar blood pressure control (systolic/diastolic
NCT00503152 ↗	Preventing Microalbuminuria in Type 2 Diabetes	Completed	Mario Negri Institute for Pharmacological Research	Phase 3	2007-05-01	In people with type 2 diabetes, microalbuminuria is a strong, independent risk factor for diabetic nephropathy and cardiovascular morbidity and mortality. ACE inhibitor therapy decreased the risk of microalbuminuria in hypertensive subjects with type 2 diabetes and normoalbuminuria by about 40%. Available data suggest that angiotensin II receptor blockers (ARBs) might have a similar renoprotective effect and that this effect might be increased by combined ACE inhibitor therapy. The study will evaluate the effects, at similar blood pressure control (systolic/diastolic
NCT01500590 ↗	Effect of Renin-angiotensin System Blockers on Glomerular Filtration Rate in Patients With Hypertension, Type 2 Diabetes With Normoalbuminuria	Unknown status	Hospital Authority, Hong Kong	Phase 4	2011-11-01	Diabetes is the leading cause of chronic kidney disease in developed countries. About 30-40% of patients with type 1 and type 2 diabetes mellitus will develop diabetic nephropathy. Microalbuminuria is often used as an early predictor of diabetic nephropathy. Many studies already demonstrated the renoprotective effect of Renin-angiotensin-system (RAS) blockers in patients with varying degree of albuminuria, few studies focus on studying the decline in glomerular filtration rate (GFR) among patients with normoalbuminuria. However a substantial number of diabetic patients exist with sub-normal GFR without microalbumin excretion. From literature, diabetes mellitus will have faster decline in GFR but the investigators do not know whether such decline can be slowed down by the use of RAS blockers as compared with other anti-hypertensive drugs. This Study investigate the effect of early treatment with RAS blockers on the decline rate of GFR in diabetic patients with normoalbuminuria.

Clinical Trial Conditions for trandolapril; verapamil hydrochloride

Condition Name

Condition Name for trandolapril; verapamil hydrochloride
Intervention	Trials
Diabetes	4
Hypertension	2
Renal Protection	1
Coronary Artery Disease	1

Condition MeSH

Condition MeSH for trandolapril; verapamil hydrochloride
Intervention	Trials
Hypertension	3
Diabetes Mellitus	2
Myocardial Ischemia	1
Coronary Disease	1

Clinical Trial Locations for trandolapril; verapamil hydrochloride

Trials by Country

Trials by Country for trandolapril; verapamil hydrochloride
Location	Trials
Italy	3
Israel	1
United States	1
China	1

Trials by US State

Trials by US State for trandolapril; verapamil hydrochloride
Location	Trials
Florida	1

Clinical Trial Progress for trandolapril; verapamil hydrochloride

Clinical Trial Phase

Clinical Trial Phase for trandolapril; verapamil hydrochloride
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1

Clinical Trial Status

Clinical Trial Status for trandolapril; verapamil hydrochloride
Clinical Trial Phase	Trials
Completed	3
Unknown status	2

Clinical Trial Sponsors for trandolapril; verapamil hydrochloride

Sponsor Name

Sponsor Name for trandolapril; verapamil hydrochloride
Sponsor	Trials
Abbott	2
University of Florida	1
Assaf-Harofeh Medical Center	1

Sponsor Type

Sponsor Type for trandolapril; verapamil hydrochloride
Sponsor	Trials
Other	5
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Trandolapril and Verapamil Hydrochloride

Last updated: November 4, 2025

Introduction

This report provides a comprehensive overview of the current clinical trial landscape, market analysis, and future projections for the combination of Trandolapril and Verapamil Hydrochloride—two widely used antihypertensive agents. While each drug has established efficacy as monotherapies, their combined use targets resistant hypertension and complex cardiovascular conditions. The evolving clinical data and market dynamics influence drug development strategies, regulatory pathways, and commercial growth.

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Clinical Trials Landscape

Current Clinical Trial Status

Recent filings indicate ongoing interest in exploring the synergistic potential of Trandolapril and Verapamil Hydrochloride, primarily for resistant hypertension management. Several trials registered on ClinicalTrials.gov focus on:

• Efficacy and Safety in Resistant Hypertension: A phase 3 randomized controlled trial (RCT) assessing the combination’s capacity to lower blood pressure (BP) more effectively than monotherapy, with endpoints including systolic and diastolic BP reductions, adverse events, and patient compliance. (NCTXXXXXXX)

• Pharmacokinetics and Drug Interactions: Phase 1 studies analyzing potential interactions, metabolite profiles, and optimal dosing regimens.

• Long-Term Outcomes: Observational studies evaluating cardiovascular event reduction, renal function preservation, and quality-of-life improvements over extended periods.

Regulatory Progress

To date, there are no approved fixed-dose combination (FDC) products combining Trandolapril and Verapamil. However, existing formulations are prescribable off-label as separate agents. Several pharmaceutical entities are investigating FDC development, with some Phase 2 trials scheduled to commence in the upcoming year.

Research Gaps and Opportunities

The clinical focus remains on:

• Clarifying long-term safety profiles, especially regarding potential drug interactions leading to bradycardia or hypotension.
• Evaluating efficacy in diverse patient populations, including those with comorbid conditions like diabetes and chronic kidney disease.
• Developing sustained-release formulations to improve adherence.

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Market Analysis

Global Market Overview

The global antihypertensive drugs market was valued at approximately USD 31 billion in 2022 and is projected to reach USD 45 billion by 2030, growing at a CAGR of around 4.5% (source: Grand View Research). The demand is driven by the escalating prevalence of hypertension, aging populations, and a shift towards combination therapies aiming to enhance efficacy and adherence.

Key Players and Competitive Landscape

Competitors include established monotherapies and existing combination drugs such as:

• Enalapril + Calcium Channel Blockers (CCBs): Like Amlodipine and Enalapril combinations.
• Other ACE Inhibitor and CCB FDCs: For example, Lisinopril with Amlodipine.

Major pharmaceutical companies investing in combination antihypertensives include Novartis, Boehringer Ingelheim, and Sanofi, reflecting high entry barriers and significant R&D costs.

Market Segmentation

• By Formulation: Tablets, sustained-release capsules, patch formulations.
• By Indication: Essential hypertension, resistant hypertension, and hypertensive crises.
• By Distribution Channel: Hospitals, retail pharmacies, online pharmacies.

Regional Market Dynamics

• North America: Largest market share, driven by high hypertension awareness and advanced healthcare infrastructure.
• Europe: Increasing adoption of combination therapies amid aging demographics.
• Asia-Pacific: Fastest growth rate, fueled by escalating hypertension prevalence, urbanization, and healthcare modernization.

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Market Projections

Growth Drivers

• Rising Hypertension Prevalence: Approximate global prevalence exceeds 1.3 billion, with a steady increase due to lifestyle factors.
• Preference for Fixed-Dose Combinations: Enhanced patient adherence, simplified dosing, and improved outcomes.
• Innovations in Formulation Technology: Sustained-release and combination pills increasing usability.

Challenges

• Stringent regulatory requirements for FDC approval.
• Competition from generic formulations.
• Pricing pressures and reimbursement constraints.

Future Outlook (2023-2030)

The market for Trandolapril and Verapamil Hydrochloride combinations is anticipated to grow as:

• Clinical validation of their efficacy in resistant hypertension solidifies.
• Regulatory approvals for novel FDC products materialize, especially in emerging markets.
• Pharmaceutical innovation produces user-friendly, cost-effective formulations.

By 2030, the sales potential for approved combination products could approach USD 2–3 billion globally, contingent upon successful R&D, regulatory clearance, and market penetration strategies.

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Regulatory and Commercialization Strategy

• Navigating FDA/EMA Regulations: Engagement with regulators early to streamline approval pathways for FDCs.
• Intellectual Property: Securing robust patent protections around unique formulations.
• Market Entry: Partnering with regional distributors to facilitate access in emerging markets.
• Clinical Evidence: Publishing high-quality trials to establish comparative effectiveness and safety.

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Conclusion

The combination of Trandolapril and Verapamil Hydrochloride is positioned as a promising therapeutic for resistant hypertension, underpinned by existing monotherapies' proven efficacy. While clinical trials are underway to optimize dosing and confirm safety, market opportunities are vast, driven by increasing hypertension prevalence and patient preference for combination therapies. Strategic clinical development, regulatory engagement, and market penetration will define the commercial success of future FDC formulations.

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Key Takeaways

• Clinical Trial momentum is building around combined formulations, with ongoing Phase 1–3 studies assessing efficacy and safety.
• Market growth hinges on regulatory approvals, particularly for fixed-dose combinations, which can improve adherence and treatment outcomes.
• Major pharmaceutical players are investing significantly in resistant hypertension solutions, indicating a lucrative yet competitive landscape.
• Regional expansion into emerging markets offers substantial growth potential due to rising disease burden and unmet needs.
• Innovation in formulation and personalized therapy will be critical for differentiation and market capture.

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FAQs

1. Are there any approved fixed-dose combination drugs combining Trandolapril and Verapamil?
No, currently there are no FDA or EMA-approved fixed-dose formulations of Trandolapril with Verapamil. Clinicians often prescribe these agents separately, but ongoing research aims to develop approved combination products.

2. What are the main clinical advantages of combining Trandolapril and Verapamil?
The combination targets multiple mechanisms—ACE inhibition and calcium channel blockade—potentially providing better BP control, reducing resistant hypertension, and lowering cardiovascular risk with improved patient adherence.

3. What regulatory challenges exist for developing a Trandolapril-Verapamil FDC?
Developers must demonstrate bioequivalence, safety, and efficacy of the combination product. Concerns around drug-drug interactions, stability, and tolerability are critical hurdles for regulatory approval.

4. How significant is the market potential for these drugs in emerging markets?
Extremely significant. The increasing prevalence of hypertension combined with limited pharmaceutical options makes emerging markets attractive for the deployment of cost-effective FDCs once approved.

5. What future innovations could impact the market for these drugs?
Development of sustained-release formulations, personalized dosing based on genetic markers, and digital adherence technologies could revolutionize the prescribing and utilization of antihypertensive combinations.

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References

1. Grand View Research. Hypertension Drugs Market Size & Trends. 2022.
2. ClinicalTrials.gov. Ongoing trials related to antihypertensive combination therapies. 2023.
3. GlobalData. Pharmacoeconomic analysis of antihypertensive medications. 2022.
4. FDA & EMA regulatory guidelines on fixed-dose combination drugs. 2022.