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
CABG	1
Hypotension on Induction	1

Condition MeSH

Condition MeSH for Quinapril Hydrochloride
Intervention	Trials
Hypertension	10
Diabetes Mellitus	4
Coronary Artery Disease	2
Diabetic Neuropathies	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
Turkey	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
National Heart, Lung, and Blood Institute (NHLBI)	2

Sponsor Type

Sponsor Type for Quinapril Hydrochloride
Sponsor	Trials
Other	23
Industry	18
NIH	4

Quinapril Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Quinapril Hydrochloride

Quinapril hydrochloride, a member of the angiotensin-converting enzyme (ACE) inhibitors family, is widely used in the management of hypertension and congestive heart failure. Here, we delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Development and Trials

Initial Clinical Studies

The clinical development of quinapril hydrochloride began with pharmacokinetic and pharmacological studies to establish its dose range and effects on human hemodynamics and blood pressure. These initial studies supported the recommendation of a once-daily dosage of 10-40 mg as first-line therapy for hypertension, often used in conjunction with diuretics for severe cases[1].

Efficacy in Hypertension

Clinical trials have consistently shown that quinapril hydrochloride is effective in reducing blood pressure in patients with mild to moderate hypertension. It has also been found to be the most potent ACE inhibitor in binding to tissue ACE, contributing to its sustained duration of action[1].

Use in Congestive Heart Failure

Quinapril has been evaluated in patients with congestive heart failure, with initial findings indicating therapeutic benefits at doses of 10-20 mg/day, administered twice daily, often in combination with diuretics or digitalis[1].

Safety Profile

The safety of quinapril hydrochloride has been established in over 2700 patients. It is considered a safe and well-tolerated antihypertensive medication with a favorable safety profile compared to other ACE inhibitors. However, there is a noted lack of recent clinical trials and post-marketing data, which has limited its widespread use[4].

Market Analysis

Current Market Size

As of 2023, the global Quinapril Hydrochloride market was valued at approximately $223 million. This market is segmented by type (capsule, tablet), application (hypertension, congestive heart failure), and geography (North America, Europe, Asia-Pacific, etc.)[5].

Market Growth Projections

The market is anticipated to grow significantly, reaching $318 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.2%. This growth is driven by increasing demand for effective antihypertensive medications and the expanding prevalence of cardiovascular diseases[5].

Key Market Drivers

• Increasing Prevalence of Hypertension and Heart Failure: The rising incidence of hypertension and heart failure globally is a major driver for the Quinapril Hydrochloride market.
• Favorable Safety Profile: Quinapril's safety profile, particularly its tolerance in elderly populations and those who cannot tolerate other ACE inhibitors, is a significant market driver[4].
• Market Dynamics: The market is influenced by factors such as product pricing, national GDP, and consumer behavior, which collectively support the growth of the Quinapril Hydrochloride market[2].

Market Restraints

• Limited Recent Clinical Trials: The lack of recent clinical trials and post-marketing data has limited the widespread adoption of quinapril hydrochloride[4].
• Competition from Other ACE Inhibitors: The presence of other well-established ACE inhibitors in the market poses a competitive challenge to quinapril hydrochloride[4].

Market Segmentation

By Type

The market is segmented into capsules and tablets, with each form having its own market share and growth prospects. The choice between these forms often depends on patient preference and clinical requirements[2].

By Application

Quinapril hydrochloride is primarily used for hypertension and congestive heart failure. Its efficacy in these areas drives the market demand, with hypertension being the larger segment[2].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, and other regions. Each region has its own growth trajectory, influenced by local healthcare policies, economic conditions, and disease prevalence[2].

Key Players

The Quinapril Hydrochloride market includes several key players such as HPGC, QR Pharmaceutical, Teva, ANI Pharmaceuticals, Apotex Pharmaceutical, Aurobindo Pharma, Sanofi, and Pfizer, among others. These companies play a crucial role in manufacturing, distribution, and marketing of the drug[2].

Market Outlook

Porter's 5 Forces Framework

The market analysis includes an evaluation using Porter's 5 Forces Framework, which examines the competitive rivalry, threat of new entrants, threat of substitute products, bargaining power of suppliers, and bargaining power of buyers. This framework helps in understanding the overall market dynamics and potential future trends[2].

Macroeconomic Assessments

Macroeconomic factors such as national GDP, healthcare expenditure, and demographic changes are critical in shaping the market outlook. These factors influence the demand for quinapril hydrochloride and its growth prospects[2].

Value Chain Analysis

A detailed value chain analysis highlights the various stages from production to distribution and how each stage impacts the final product. This analysis is essential for understanding the cost structure and potential areas for improvement[2].

Future Projections

Growth Trends

The Quinapril Hydrochloride market is expected to continue its upward trend, driven by the increasing demand for antihypertensive medications and the expanding global healthcare market. The market is projected to reach $318 million by 2030, with a CAGR of 5.2% from 2023 to 2030[5].

Emerging Opportunities

There are emerging opportunities for quinapril hydrochloride, particularly in the treatment of heart failure with preserved ejection fraction and in elderly populations who may not tolerate other ACE inhibitors. These opportunities could further boost the market growth[4].

Key Takeaways

• Clinical Efficacy: Quinapril hydrochloride is effective in managing hypertension and congestive heart failure.
• Safety Profile: It has a favorable safety profile, making it a viable option for patients who cannot tolerate other ACE inhibitors.
• Market Growth: The market is projected to grow significantly, reaching $318 million by 2030.
• Key Drivers: Increasing prevalence of hypertension and heart failure, and its favorable safety profile are key market drivers.
• Market Segmentation: The market is segmented by type, application, and geography, each with its own growth prospects.

FAQs

What is the primary use of quinapril hydrochloride?

Quinapril hydrochloride is primarily used for the treatment of hypertension and congestive heart failure.

What is the recommended dosage of quinapril hydrochloride?

The recommended dosage is typically 10-40 mg once daily for hypertension, and 10-20 mg twice daily for congestive heart failure, depending on the patient's condition and renal function[1][3].

What are the key drivers of the Quinapril Hydrochloride market?

The key drivers include the increasing prevalence of hypertension and heart failure, and the favorable safety profile of quinapril hydrochloride[4][5].

Who are the key players in the Quinapril Hydrochloride market?

Key players include HPGC, QR Pharmaceutical, Teva, ANI Pharmaceuticals, Apotex Pharmaceutical, Aurobindo Pharma, Sanofi, and Pfizer, among others[2].

What is the projected market size of Quinapril Hydrochloride by 2030?

The market is projected to reach $318 million by 2030, with a CAGR of 5.2% from 2023 to 2030[5].

Sources

1. Overview of the clinical development of quinapril - PubMed
2. Quinapril Hydrochloride Market Size, Scope And Forecast Report - Market Research Intellect
3. ACCUPRIL® (quinapril HCl) - Pfizer Medical Information - US
4. Benefit and risk evaluation of quinapril hydrochloride - PubMed
5. Global Quinapril Hydrochloride Market Research Report 2024 - Market Research Reports