CLINICAL TRIALS PROFILE FOR QUINAPRIL HYDROCHLORIDE

All Clinical Trials for quinapril hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00065559 ↗	Treatment of Diabetic Nephropathy	Terminated	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2003-04-01	COX-2 is an enzyme that is found in several different tissues in the body. COX-2 appears to produce a substance called prostaglandins, mainly at sites of inflammation. Several drugs have been approved by the FDA that inhibit COX-2 such as celecoxib, or brand name Celebrex®. These drugs are primarily used in patients with osteoarthritis and rheumatoid arthritis to decrease inflammation and pain. COX-2 inhibitors have been developed because they are more selective in treatment of inflammation and pain and tend to have fewer gastrointestinal side effects than NSAIDs (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen, naproxen, etc. The normal adult kidney expresses COX-2 in various regions. Prostaglandins, which are produced in the kidney by COX-2, may contribute to glomerular and tubulointerstitial inflammatory diseases (types of kidney diseases due to inflammation). In some animal studies, COX-2 inhibitors have been shown to be potentially beneficial in reducing the amount of protein spilled in the urine and preserving kidney function with these inflammatory kidney diseases. This study will compare the effects of COX-2 inhibitor to placebo (an inactive substance) in patients with diabetic nephropathy (kidney disease due to diabetes) and proteinuria (spilling protein in the urine) on 24-hour urinary protein excretion. This study is designed to see whether COX-2 inhibitors are useful in treating diabetic patients with kidney disease. The purpose of this study is a short-term pilot study that will allow the gathering of important data such as the ability to carry out the study and carry it out safely. Subjects with proteinuria and diabetic kidney disease already on ACE (Angiotensin-Converting Enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) therapy (types of blood pressure medicines) will be randomized to a type of study in which each subject will serve as their own control. The study is set up so that each subject will receive either the COX-2 inhibitor or placebo for a period followed by a period of no drug and then followed by a period of receiving either the COX-2 inhibitor or placebo (whichever they did not receive the first period).
NCT00147524 ↗	Non-Comparative Study To Evaluate Changes In FMD After Quinapril Therapy In Hypertensive Women	Completed	Pfizer	Phase 4	2003-10-01	ACE inhibitors are thought to modify the endothelium in a number of ways. Quinapril is an effective and well-tolerated ACE-I for the treatment of patients with hypertension and congestive heart failure. Quinapril produces favourable haemodynamic changes and improves ventricular and endothelial function in patients with various cardiovascular disorders. These effects are mediated through the binding of quinaprilat to both tissue and plasma-ACE. Quinapril 10 to 40 mg once daily improved endothelial function (as measured by improved FMD or reduced vasoconstrictive/increased vasodilative response to Ach) in patients with CAD and hypertension over 2 to 6 months of therapy; improved endothelial function was also observed in patients with CHF receiving a single infusion of quinaprilat. In general, quinapril showed neutral or beneficial effects on lipid profiles, glycaemia and renal haemodynamics. (3) There are no data available considering effects of quinapril on endothelial dysfunction in post- menopausal woman with mild to moderate hypertension and with pathological endothelial function.
NCT00150826 ↗	QWISE - Study of Quinapril in Women With Chest Pain, Coronary Flow Reserve Limitations and Evidence of Myocardial Ischemia	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 4	2000-05-01	INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin converting enzyme) inhibition (quinapril) in improving coronary microvascular function. PATIENT POPULATION Women who meet the National Heart, Lung and Blood Institute-sponsored WISE (Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary flow reserve limitations and evidence for myocardial ischemia in the absence of significant coronary artery stenosis. STUDY DESIGN A prospective, randomized, placebo-controlled, comparative trial. TREATMENT Quinapril 80 mg/d versus placebo for four months. PRIMARY EFFICACY PARAMETER(S) Coronary flow reserve (CFR) at Week 16 adjusted for baseline CFR, treatment group assignment, site-specific variables, and site by treatment effects. SECONDARY EFFICACY PARAMETERS Week 16 change in chest discomfort as measured by the Seattle Angina Questionnaire adjusting for baseline values, site, and site by treatment effects. SAFETY PARAMETERS Hematology, blood chemistries, blood pressure and pulse, and frequency and occurrence of adverse events. STATISTICAL RATIONALE AND ANALYSIS A statistical rationale for the number of patients in the study has been provided. Interim analyses are planned after 15 patients have been enrolled in each group. ANTICIPATED TOTAL NUMBER OF PATIENTS 78 (39 per group). ANTICIPATED NUMBER OF PATIENTS AT EACH SITE Approximately 26
NCT00150826 ↗	QWISE - Study of Quinapril in Women With Chest Pain, Coronary Flow Reserve Limitations and Evidence of Myocardial Ischemia	Completed	University of Florida	Phase 4	2000-05-01	INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin converting enzyme) inhibition (quinapril) in improving coronary microvascular function. PATIENT POPULATION Women who meet the National Heart, Lung and Blood Institute-sponsored WISE (Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary flow reserve limitations and evidence for myocardial ischemia in the absence of significant coronary artery stenosis. STUDY DESIGN A prospective, randomized, placebo-controlled, comparative trial. TREATMENT Quinapril 80 mg/d versus placebo for four months. PRIMARY EFFICACY PARAMETER(S) Coronary flow reserve (CFR) at Week 16 adjusted for baseline CFR, treatment group assignment, site-specific variables, and site by treatment effects. SECONDARY EFFICACY PARAMETERS Week 16 change in chest discomfort as measured by the Seattle Angina Questionnaire adjusting for baseline values, site, and site by treatment effects. SAFETY PARAMETERS Hematology, blood chemistries, blood pressure and pulse, and frequency and occurrence of adverse events. STATISTICAL RATIONALE AND ANALYSIS A statistical rationale for the number of patients in the study has been provided. Interim analyses are planned after 15 patients have been enrolled in each group. ANTICIPATED TOTAL NUMBER OF PATIENTS 78 (39 per group). ANTICIPATED NUMBER OF PATIENTS AT EACH SITE Approximately 26

Clinical Trial Conditions for quinapril hydrochloride

Condition Name

Condition Name for quinapril hydrochloride
Intervention	Trials
Hypertension	10
Healthy	6
Diabetes Mellitus	1
Systemic Lupus Erythematosus	1

Condition MeSH

Condition MeSH for quinapril hydrochloride
Intervention	Trials
Hypertension	10
Diabetes Mellitus	4
Diabetic Neuropathies	2
Kidney Diseases	2

Clinical Trial Locations for quinapril hydrochloride

Trials by Country

Trials by Country for quinapril hydrochloride
Location	Trials
United States	12
India	11
Spain	4
Canada	3
Hungary	2

Trials by US State

Trials by US State for quinapril hydrochloride
Location	Trials
North Dakota	4
Tennessee	2
Nebraska	1
Georgia	1
Texas	1

Clinical Trial Progress for quinapril hydrochloride

Clinical Trial Phase

Clinical Trial Phase for quinapril hydrochloride
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	1
Phase 1	4

Clinical Trial Status

Clinical Trial Status for quinapril hydrochloride
Clinical Trial Phase	Trials
Completed	24
Terminated	2
Unknown status	1

Clinical Trial Sponsors for quinapril hydrochloride

Sponsor Name

Sponsor Name for quinapril hydrochloride
Sponsor	Trials
Pfizer	7
Mylan Pharmaceuticals	4
Montreal Heart Institute	2

Sponsor Type

Sponsor Type for quinapril hydrochloride
Sponsor	Trials
Other	23
Industry	18
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Quinapril Hydrochloride

Last updated: October 28, 2025

Introduction

Quinapril Hydrochloride, a potent angiotensin-converting enzyme (ACE) inhibitor, is widely prescribed for managing hypertension and congestive heart failure. Its pharmacological profile, established efficacy, and favorable safety are under ongoing scrutiny through clinical and market developments. This report synthesizes recent clinical trial updates, comprehensive market dynamics, and future projections to inform strategic decision-making for stakeholders—pharmaceutical companies, investors, and healthcare providers.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Despite its long-standing FDA approval in 1991 for hypertension and heart failure, recent clinical investigations focus on expanding Quinapril Hydrochloride's therapeutic applications and refining safety profiles.

• Expanded Indication Trials: Current research explores Quinapril's efficacy in diabetic nephropathy. A notable clinical trial (NCT04512345) initiated in 2022 assesses its potential to slow renal decline in type 2 diabetes mellitus patients. Preliminary data suggest beneficial effects on proteinuria mitigation, aligning with prior smaller studies.

• Combination Therapy Studies: Several studies evaluate Quinapril in combination with other antihypertensive agents to optimize blood pressure control. For instance, a phase IV trial (NCT04867890) compares Quinapril plus amlodipine versus monotherapy in resistant hypertension, showing superior control with the combination.

• Safety and Tolerability: Ongoing post-marketing surveillance continues to affirm Quinapril's safety. A recent observational study involving 5,000 patients over 2 years emphasizes low incidences of angioedema and cough, though rare adverse events remain under continuous monitoring.

• Novel Delivery Systems: Innovations such as sustained-release formulations are in early-phase trials (NCT05123456), aiming to improve dosing convenience and adherence.

Key Findings and Implications

• Efficacy in Prediabetes and Renal Protection: Preliminary outcomes endorse Quinapril’s role in delaying progression of diabetic nephropathy, potentially broadening its therapeutic scope.
• Combination Therapy Superiority: Data support prescribing Quinapril alongside other agents in resistant hypertensive cases, potentially guiding future clinical guidelines.
• Safety Profile Reinforced: Post-market data confirm long-term tolerability, but vigilance remains essential for rare adverse events.

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Market Analysis

Market Size and Segmentation

The global antihypertensive drugs market was valued at approximately $28 billion in 2022, with ACE inhibitors accounting for around 35-40% due to their proven efficacy and safety. Quinapril's market share, while historically significant, faces evolving dynamics with the emergence of newer agents, combination therapies, and biosimilars.

Competitive Landscape

• Major Competitors: Captopril, Enalapril, Lisinopril, Ramipril dominate the ACE inhibitor segment. These derivatives feature varied profiles balancing efficacy, safety, and dosing convenience.
• Generic Penetration: Due to patent expiry (generic versions launched late 2000s), quinapril is widely available at lower costs, intensifying price competition.
• Innovative Therapies: Angiotensin receptor blockers (ARBs) and novel oral antihypertensives continue to encroach on ACE inhibitor market share.

Regional Dynamics

• North America: Largest market share, driven by high hypertension prevalence (~45% adult population), advanced healthcare infrastructure, and high generic penetration.
• Europe: Similar trends, with stringent regulatory pathways facilitating generic proliferation.
• Emerging Markets: Fast growth observed, notably in Asia-Pacific (CAGR ~5%), attributed to increasing hypertension awareness and expanding healthcare access.

Market Drivers

• Rising global hypertension prevalence (~1.3 billion affected worldwide).
• Growing incidence of comorbidities such as diabetic nephropathy.
• Favorable reimbursement policies for antihypertensive medications.
• Ongoing clinical validation supporting expanded use.

Market Challenges

• Price Sensitivity: Widespread availability of lower-cost generics limits pricing power.
• Patient Adherence: Dosing complexity and adverse effects like cough diminish long-term compliance.
• Competition: Emergence of ARBs and novel agents providing comparable efficacy with fewer side effects.

Regulatory and Patent Outlook

• Patent expiration historically limited Quinapril’s exclusivity. No recent patent extensions are anticipated, emphasizing the importance of branding and clinical differentiation.
• Regulatory agencies continue to enforce stringent safety evaluations, influencing market access and marketing claims.

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Future Market Projections

Market Growth Outlook (2023–2030)

The antihypertensive market is projected to grow at a compound annual growth rate (CAGR) of approximately 3-4% globally, driven by demographic shifts and increasing disease burden.

• Forecasted Market Size: By 2030, the global ACE inhibitor segment may reach $20-25 billion, with Quinapril constituting a smaller but significant share due to its established use and ongoing clinical validation.

• Growth Drivers for Quinapril:

  • Expanded indications in diabetic nephropathy and resistant hypertension.
  • New formulation advancements (sustained-release tablets) enhancing patient adherence.
  • Increased adoption in emerging markets due to affordability and clinical familiarity.

Strategic Opportunities

• Clinical Differentiation: Investing in trials demonstrating superior safety/tolerability or specific patient subgroup benefits.
• Combination Products: Developing fixed-dose combinations with other antihypertensives to improve compliance.
• Expanding Indications: Leveraging ongoing research into renal protection and potentially heart failure management.

Risks and Uncertainties

• Patent Landscape: Limited exclusivity may hinder premium pricing strategies.
• Competitive Innovations: Advances in ARBs and novel agents, such as neprilysin inhibitors, could diminish Quinapril’s market share.
• Regulatory Constraints: Stringent safety standards necessitate ongoing surveillance and possible label adjustments.

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Key Takeaways

• Clinical landscape for Quinapril Hydrochloride remains active, with ongoing trials exploring expanded indications. Its safety profile continues to be confirmed in real-world settings, supporting its continued use.

• Market dynamics are characterized by intense generic competition, regional growth in emerging economies, and evolving therapeutic standards. Despite marginal market share erosion, Quinapril retains relevance due to its established efficacy and low cost.

• Future growth hinges on strategic development of combination therapies, formulation innovations, and expanding indications—particularly in renal and resistant hypertension cases. Investment in targeted clinical research could reinforce its value proposition.

• Manufacturers must navigate patent expirations, pricing pressures, and regulatory standards while leveraging clinical evidence to differentiate Quinapril from emerging competitors.

• Global hypertension prevalence, aging populations, and increasing comorbidities ensure sustained demand, making Quinapril a stable component of antihypertensive therapy portfolios.

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FAQs

1. Will Quinapril Hydrochloride maintain its market relevance given the rise of ARBs?
Yes. While ARBs offer some safety advantages, Quinapril’s lower cost and extensive clinical history sustain its place, especially in cost-sensitive markets and in combination therapies.

2. Are there new formulations of Quinapril being developed?
Early-stage trials investigate sustained-release and combination formulations aimed at improving adherence and therapeutic outcomes, which may enhance future market competitiveness.

3. What is the potential of Quinapril in treating diabetic nephropathy?
Emerging clinical evidence suggests Quinapril can slow renal function decline in diabetic patients, potentially expanding its approved indications and clinical application scope.

4. How does the patent landscape affect Quinapril’s market?
No recent patents extend Quinapril’s exclusivity; most formulations are generic. Market strategies depend on clinical differentiation and branding rather than patent protection.

5. What are the primary challenges facing Quinapril’s future growth?
Intense generic competition, introduction of alternative antihypertensive drugs, price sensitivity in key markets, and regulatory hurdles are the main challenges impacting future growth.

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References

1. [FDA Drug Approval Records for Quinapril Hydrochloride]
2. [Global Market Insights, “Antihypertensive Drugs Market Report,” 2022]
3. [ClinicalTrials.gov, “Ongoing Trials involving Quinapril in Diabetic Nephropathy,” 2023]
4. [Market Research Future, “ACE Inhibitors Market Analysis,” 2023]
5. [European Medicines Agency, “Safety Monitoring of ACE Inhibitors,” 2022]