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

Clinical Trial Conditions for TRANDOLAPRIL

Condition Name

Condition Name for TRANDOLAPRIL
Intervention	Trials
Hypertension	7
Diabetes	5
Healthy	4
Diabetic Nephropathy	1

Condition MeSH

Condition MeSH for TRANDOLAPRIL
Intervention	Trials
Hypertension	6
Kidney Diseases	2
Diabetic Nephropathies	2
Coronary Disease	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
Denmark	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

Trandolapril: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is trandolapril and where is it used?

Trandolapril is an angiotensin-converting enzyme (ACE) inhibitor used for cardiovascular indications, most prominently:

• Hypertension
• Heart failure
• Reduction of cardiovascular events in select high-risk patient populations (class effect and indication-specific labels vary by jurisdiction)

Regulatory posture: trandolapril is an established, off-patent small-molecule in most major markets, which typically shifts the investment case away from patent life extension and toward line extensions, combination products, and competitive positioning.

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What does the current clinical-trials landscape show for trandolapril?

A complete, up-to-date “clinical trials update” requires an authoritative live registry pull (e.g., ClinicalTrials.gov, EU Clinical Trials Register) for active studies, recruitment status, study design, endpoints, and sponsor. That level of granularity is not available from the information provided here.

Result: No complete and accurate trial-by-trial update can be produced under the operating constraints.

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What is the market size for trandolapril today?

A defensible market sizing and forecast also requires current commercial baselines (sales by geography, channel mix, and reference for market definition) from a source such as IQVIA, EvaluatePharma, or comparable market research datasets. Those figures are not available in the provided material.

Result: No complete and accurate market analysis or numeric projection can be produced under the operating constraints.

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What are the drivers that move trandolapril demand?

Even without live trial or numeric market datasets, trandolapril demand is shaped by structural factors that are consistent across mature ACE-inhibitor markets:

Supply and access

• Generic competition limits unit economics and keeps pricing low after patent expiry.
• Formulation line-ups (tablets, fixed-dose combinations) drive substitution patterns when payers standardize formularies.

Therapeutic substitution

• ACE inhibitors compete with ARBs, direct renin inhibitors (limited penetration), and in some settings beta-blockers and MRAs as guideline-based bundles of therapy.
• Switch behavior is guided by tolerability (e.g., cough and angioedema risk across ACE inhibitors) and outcome-driven protocols.

Payer and guideline dynamics

• Formularies usually prefer a small set of low-cost agents; trandolapril price discipline is therefore a key determinant of share stability.
• Guideline cycles affect whether ACE inhibitors retain first-line positioning versus ARBs for specific risk groups.

Safety and risk management

• ACE inhibitor class risks (not unique to trandolapril) drive ongoing pharmacovigilance requirements and influence uptake in sensitive populations.

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What is the near-term outlook for trandolapril (projection framework)?

A projection requires numeric anchors (current sales, CAGR baseline, elasticity assumptions, and competitive scenario). Without those anchors, any forecast would not be complete and accurate.

Result: No quantified projection can be produced under the operating constraints.

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Where can trandolapril still win in a mature market?

With an off-patent backbone, the actionable routes typically focus on commercial execution rather than fundamental clinical differentiation:

• Fixed-dose combinations that match guideline drug pairing patterns
• Bioequivalence and manufacturing robustness to reduce supply disruption risk
• Payer contracting (tender participation and preferred formulary placement)
• Branding strategy around dosing convenience (where applicable) rather than differentiated efficacy

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Key Takeaways

• Trandolapril is an established ACE inhibitor used across hypertension and heart failure-related indications.
• A complete, current clinical-trials update requires live registry data; it cannot be produced from the information provided here.
• A market size and numeric forecast require current commercial baselines and a market-definition reference; they cannot be produced from the information provided here.
• In mature ACE-inhibitor markets, share and pricing are primarily driven by generics competition, payer formularies, and fixed-dose product strategy.

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FAQs

1) Is trandolapril still under patent protection globally?
In most major markets, trandolapril is widely available as a generic; however, patent status is jurisdiction- and product-specific.

2) Does trandolapril have ongoing disease-modifying trial claims?
ACE inhibitor class evidence is established, but a current, trandolapril-specific trial update requires registry confirmation.

3) What end markets matter most for trandolapril?
Cardiovascular care through ambulatory and chronic-disease prescribing, with payer formularies heavily influencing share.

4) How does generic competition affect pricing and growth prospects?
It compresses pricing and shifts growth from “new adoption” to “share retention” and product mix optimization (including combinations).

5) What product strategy typically supports share in mature ACE inhibitor markets?
Fixed-dose combinations, reliable supply, and preferred formulary positioning.

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References

No sources were provided in the prompt, and no registry or market dataset was included; therefore, no citations can be listed.