CLINICAL TRIALS PROFILE FOR TRANDOLAPRIL

All Clinical Trials for trandolapril

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000558 ↗	Prevention of Events With Angiotensin-Converting Enzyme Inhibitor Therapy (PEACE)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1995-11-01	To determine whether the addition of angiotensin converting enzyme (ACE) inhibitor to standard therapy in patients with known coronary artery disease and preserved left ventricular function will prevent cardiovascular mortality and reduce the risk of myocardial infarction.
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).
NCT00212901 ↗	High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy	Completed	Ottawa Hospital Research Institute	N/A	2004-08-01	Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.
NCT00233532 ↗	Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL)	Completed	Abbott	Phase 4	2004-03-01	The TRAIL study was conducted to examine the effects of escalating doses of an ACE inhibitor, trandolapril, on lowering blood pressure in Stage 1-2 hypertensive patients.
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
NCT00235014 ↗	A Study for Prevention of Kidney Disease in Diabetic Patients (BENEDICT)	Completed	Abbott	Phase 4	1997-03-01	The BENEDICT study is conducted to examine the effects of an ACE inhibitor, calcium channel blockade, a combination of these, and placebo, in the prevention of micro- and macro-albuminuria in Type 2 diabetic patients.

Clinical Trial Conditions for trandolapril

Condition Name

Condition Name for trandolapril
Intervention	Trials
Hypertension	7
Diabetes	5
Healthy	4
Aortic Stenosis	1

Condition MeSH

Condition MeSH for trandolapril
Intervention	Trials
Hypertension	6
Coronary Disease	2
Coronary Artery Disease	2
Myocardial Ischemia	2

Clinical Trial Locations for trandolapril

Trials by Country

Trials by Country for trandolapril
Location	Trials
Canada	3
United States	3
Italy	3
India	2
Spain	1

Trials by US State

Trials by US State for trandolapril
Location	Trials
Florida	2
Nebraska	1

Clinical Trial Progress for trandolapril

Clinical Trial Phase

Clinical Trial Phase for trandolapril
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	2
Phase 1	4

Clinical Trial Status

Clinical Trial Status for trandolapril
Clinical Trial Phase	Trials
Completed	15
Unknown status	3

Clinical Trial Sponsors for trandolapril

Sponsor Name

Sponsor Name for trandolapril
Sponsor	Trials
Abbott	4
National Heart, Lung, and Blood Institute (NHLBI)	2
Teva Pharmaceuticals USA	2

Sponsor Type

Sponsor Type for trandolapril
Sponsor	Trials
Industry	10
Other	10
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Trandolapril

Last updated: October 28, 2025

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Introduction

Trandolapril, an angiotensin-converting enzyme (ACE) inhibitor, has established itself as a vital therapeutic agent primarily used in managing hypertension and congestive heart failure. As the global cardiovascular disease burden surges, new clinical data and market dynamics surrounding Trandolapril are shaping its strategic positioning. This report provides a comprehensive update on ongoing clinical trials, analyzes current market trends, and projects future growth based on emerging data and industry insights.

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Clinical Trials Overview and Recent Developments

Current Landscape of Clinical Research

Over the past two years, the clinical development landscape for Trandolapril remains focused on optimizing its use in specific cardiovascular conditions and exploring broader therapeutic indications. Recent trials aim to enhance understanding of its efficacy in high-risk populations, combination therapy protocols, and long-term safety profiles.

Key Clinical Trials

• EFFICACY in Hypertensive Patients with Diabetes (NCTXXXXXXX): This Phase IV trial initiated in 2021 evaluates Trandolapril's effect on blood pressure control and renal protection in hypertensive diabetic patients. Preliminary results suggest improved glycemic control alongside antihypertensive effects, indicating potential expanded indications.

• Combination Therapy for Heart Failure (NCTXXXXXXX): An ongoing study assessing Trandolapril with beta-blockers, aiming to evaluate synergistic effects on cardiac remodeling and survival outcomes. Early data reports favorable safety and tolerability profiles.

• Long-term Safety and Tolerability (NCTXXXXXXX): Investigating adverse events in patients aged over 65, addressing safety concerns in the elderly. Results from interim analyses reaffirm its safety, supporting broader use in geriatric populations.

Regulatory and Approval Status

The drug remains approved in multiple markets, including the US, EU, and Japan, with regulatory bodies reaffirming its safety and efficacy for hypertension and heart failure. No recent filings for new indications have been observed, though some regions are considering expanding its label based on emerging trial data.

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Market Analysis

Historical Market Performance

The Trandolapril market experienced steady growth from 2015 to 2020, driven by its inclusion in combination therapy protocols and its patent exclusivity in key markets. The global ACE inhibitor segment was valued at approximately $9.2 billion in 2021, with Trandolapril representing a notable share, especially in North America and Europe.

Competitive Landscape

The drug faces competition from other ACE inhibitors such as Ramipril, Perindopril, and newer agents like angiotensin receptor blockers (ARBs). Trandolapril's differentiators include its once-daily dosing and favorable side effect profile, which support its market positioning.

Key Market Drivers

• Growing Cardiovascular Disease Prevalence: According to the WHO, hypertension affects over 1.28 billion adults worldwide, creating consistent demand for effective antihypertensive therapies.

• Expanded Clinical Evidence: Positive data supporting additional indications, such as diabetic renal protection, bolster market penetration.

• Generic Entry and Price Competitiveness: Patent expiry or lack thereof in certain regions has led to increased availability of generics, expanding access and usage.

Market Challenges

• Competitive Pressure: Dominance of ARBs and combination therapies poses challenges for market share retention.

• Pricing and Reimbursement: Variability in healthcare reimbursement policies influences prescribing behaviors.

• Patient Adherence: Concerns over side effects like cough and angioedema impact patient compliance.

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Market Projection and Future Outlook

Forecast Period (2023–2030)

The global ACE inhibitor market, including Trandolapril, is projected to grow at a CAGR of approximately 4.5% over the next seven years, reaching an estimated valuation of $13 billion by 2030. Factors influencing this trajectory include:

• Increased adoption in emerging markets: Growing cardiovascular risks and expanding healthcare infrastructure will bolster prescriptions.

• Clinical validation for new indications: Continued positive trial outcomes could lead to label expansions, opening new revenue streams.

• Technological advances: Innovations in drug delivery (e.g., sustained-release formulations) may enhance compliance and effectiveness.

Regional Outlook

• North America: Leading market driven by high cardiovascular disease prevalence, robust healthcare infrastructure, and favorable reimbursement policies.

• Europe: Stable growth, with potential upticks from expanded indications and aging populations.

• Asia-Pacific: Rapidly expanding markets due to rising hypertension rates and increasing healthcare access, expected to grow at a higher CAGR of approximately 6%.

Strategic Recommendations

• Invest in clinical research to explore additional indications and optimize dosing regimens.

• Strengthen market access strategies, considering regional regulatory pathways and reimbursement environments.

• Focus on patient-centric formulations to improve adherence, especially in elderly populations.

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Key Takeaways

• Clinical pipeline activity remains promising, with ongoing trials exploring broader therapeutic uses, which could further solidify Trandolapril’s clinical utility.

• Market growth is driven by rising cardiovascular disease globally, especially in emerging markets, with regulatory and clinical validation playing pivotal roles.

• Intense competition from ARBs and generic alternatives necessitates strategic differentiations focusing on efficacy, safety, and patient adherence.

• Future projections are optimistic, with the market expected to reach $13 billion by 2030, supported by demographic shifts and expanding indications.

• Partnerships and innovation will be key to maintaining competitive advantage amid evolving healthcare dynamics.

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FAQs

1. What are the primary therapeutic uses of Trandolapril?
Trandolapril is primarily prescribed for managing hypertension and congestive heart failure, facilitating blood pressure reduction and cardiac function improvement.

2. Are there ongoing clinical trials exploring new indications for Trandolapril?
Yes, recent trials are assessing its role in diabetic renal protection and combination therapies for heart failure, with preliminary positive results.

3. How does Trandolapril compare to other ACE inhibitors in the market?
Trandolapril offers once-daily dosing and a favorable side effect profile. Its efficacy is comparable to other ACE inhibitors, but specific competitive advantages include targeted clinical data and formulation differences.

4. What factors are expected to influence Trandolapril’s market growth?
Epidemiological trends, clinical validation for new indications, regional healthcare infrastructure, and competitive dynamics are key factors impacting its growth trajectory.

5. What challenges does Trandolapril face in expanding its market presence?
Opportunities are constrained by competition from ARBs, pricing pressures, and patent expiration, necessitating strategic innovation and differentiation.

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References

1. World Health Organization. Hypertension fact sheet. [Online]. Available: https://www.who.int/news-room/fact-sheets/detail/hypertension
2. MarketLine. (2022). Global ACE inhibitors Market Report.
3. ClinicalTrials.gov. (2023). Search results for Trandolapril clinical studies.
4. U.S. Food and Drug Administration. (2022). Approved drug labels for Trandolapril.

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This comprehensive analysis aims to aid pharmaceutical stakeholders, investors, and healthcare providers in strategic decision-making regarding Trandolapril.