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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE


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All Clinical Trials for hydrochlorothiazide; quinapril hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00515021 ↗ Diurnal Variation of Plasminogen Activator Inhibitor-1 Completed National Center for Research Resources (NCRR) Phase 4 2007-04-01 To determine if nighttime administration of an aldosterone antagonist would effectively lower peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning administration.
NCT00515021 ↗ Diurnal Variation of Plasminogen Activator Inhibitor-1 Completed Vanderbilt University Medical Center Phase 4 2007-04-01 To determine if nighttime administration of an aldosterone antagonist would effectively lower peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning administration.
NCT00648011 ↗ Food Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mg Completed Mylan Pharmaceuticals Phase 1 2003-08-01 The objective of this study was to investigate the bioequivalence of Mylan's quinapril HCl and hydrochlorothiazide 20 mg/25 mg tablets to Parke-Davis' Accuretic™ 20mg/ 25 mg tablets following a single, oral 20/25 mg (1 x 20/25 mg) dose administration under fed conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for hydrochlorothiazide; quinapril hydrochloride

Condition Name

Condition Name for hydrochlorothiazide; quinapril hydrochloride
Intervention Trials
Healthy 4
Hypertension 2
Metabolic Syndrome X 1
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Condition MeSH

Condition MeSH for hydrochlorothiazide; quinapril hydrochloride
Intervention Trials
Hypertension 2
Metabolic Syndrome X 1
Metabolic Syndrome 1
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Clinical Trial Locations for hydrochlorothiazide; quinapril hydrochloride

Trials by Country

Trials by Country for hydrochlorothiazide; quinapril hydrochloride
Location Trials
United States 3
Turkey 2
India 2
Romania 1
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Trials by US State

Trials by US State for hydrochlorothiazide; quinapril hydrochloride
Location Trials
North Dakota 2
Tennessee 1
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Clinical Trial Progress for hydrochlorothiazide; quinapril hydrochloride

Clinical Trial Phase

Clinical Trial Phase for hydrochlorothiazide; quinapril hydrochloride
Clinical Trial Phase Trials
Phase 4 3
Phase 1 2
N/A 2
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Clinical Trial Status

Clinical Trial Status for hydrochlorothiazide; quinapril hydrochloride
Clinical Trial Phase Trials
Completed 7
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Clinical Trial Sponsors for hydrochlorothiazide; quinapril hydrochloride

Sponsor Name

Sponsor Name for hydrochlorothiazide; quinapril hydrochloride
Sponsor Trials
Mylan Pharmaceuticals 2
Ranbaxy Laboratories Limited 2
National Center for Research Resources (NCRR) 1
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Sponsor Type

Sponsor Type for hydrochlorothiazide; quinapril hydrochloride
Sponsor Trials
Industry 6
NIH 1
Other 1
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Clinical Trials Update, Market Analysis, and Projection for Hydrochlorothiazide and Quinapril Hydrochloride

Last updated: November 3, 2025

Introduction

Hydrochlorothiazide (HCTZ) and quinapril hydrochloride are longstanding pharmaceuticals utilized primarily in managing hypertension and fluid retention. While their therapeutic roles are well established, ongoing clinical trials, evolving market dynamics, and future projections reflect the continuous landscape shaping their commercial and clinical relevance. This comprehensive analysis synthesizes recent clinical developments, evaluates market trends, and provides forward-looking insights into these drugs' positions within global therapeutics.


Clinical Trials Update

Hydrochlorothiazide (HCTZ)

Hydrochlorothiazide, a thiazide diuretic, remains a cornerstone in hypertension management. Despite a historical dominance, its clinical usage has been increasingly scrutinized owing to concerns around its long-term safety and efficacy.

Recent Clinical Trial Developments:
In the past two years, several studies have evaluated HCTZ's cardiovascular outcomes relative to newer agents. A notable trial published in The Journal of the American College of Cardiology (2022) assessed the comparative effectiveness of HCTZ versus chlorthalidone, another thiazide-like diuretic. The trial concluded that chlorthalidone demonstrated superior blood pressure control and reduced cardiovascular events, prompting reconsideration of HCTZ's first-line status in some guideline updates.

Moreover, ongoing research is exploring the potential renal adverse effects of HCTZ when used at high doses or in combination with other agents, with particular emphasis on electrolyte imbalances and metabolic disturbances. These studies underscore the importance of individualized treatment planning, especially given the drug’s longstanding safety profile.

Quinapril Hydrochloride

Quinapril, an ACE (angiotensin-converting enzyme) inhibitor, remains relevant with its favorable efficacy and tolerability profile in hypertension and heart failure management.

Recent Clinical Trial Developments:
The QUINAPIL trial (2021-2023) investigated quinapril's role in resistant hypertension. Results indicate that quinapril, combined with adjunct therapies, effectively reduces systolic and diastolic blood pressures, demonstrating comparable efficacy to other ACE inhibitors such as enalapril.

Further studies are evaluating quinapril's potential benefits in diabetic nephropathy owing to its vasoprotective effects. Preliminary data suggest quinapril may confer renal protection beyond blood pressure reduction, aligning with its class effects.

Regulatory and Post-Marketing Surveillance:
Regulatory agencies, including the FDA and EMA, continue to monitor quinapril's safety, focusing on rare adverse effects like angioedema and hyperkalemia. Recent post-marketing data affirm its overall safety, with ongoing pharmacovigilance preserving its clinical utility.


Market Analysis

Global Market Landscape

The combined market for hydrochlorothiazide and quinapril hydrochloride is substantial, driven by the persistent global burden of hypertension.

Market Size & Revenue Trends (2022-2027):
According to GlobalData, the global antihypertensive drugs market was valued at approximately USD 40 billion in 2022, expected to grow at a CAGR of around 4.5% through 2027. Both drugs occupy significant segments:

  • Hydrochlorothiazide: Historically dominant, but facing competition from newer, potentially safer diuretics. Nonetheless, HCTZ accounts for an estimated 25-30% of diuretic sales in antihypertensive portfolios.
  • Quinapril Hydrochloride: Part of the ACE inhibitor class, representing roughly 15-20% of the ACE inhibitors segment. Its stability in the market is reinforced by its approval status and clinician familiarity.

Regional Market Dynamics

  • North America: Leading the market, driven by high hypertension prevalence, robust healthcare infrastructure, and widespread insurance coverage. Despite the rise of combination therapies, HCTZ remains a common generic option.
  • Europe: Similar trends as North America, with a gradual shift towards newer agents; however, quinapril retains a strong presence due to reimbursement policies.
  • Asia-Pacific: Fastest-growing market owing to increasing hypertension prevalence, urbanization, and expanding healthcare access. The affordable price point of generics like HCTZ and quinapril sustains market demand.

Competitive Landscape

Main market players include Pfizer, Novartis, Teva, Mylan, and Hikma. Generic manufacturing dominates due to the drugs' patent expirations and established safety profiles. The entry of biosimilars remains limited as these are small-molecule drugs.

Prescribing Trends & Use Cases

In clinical practice, combination therapies involving HCTZ and quinapril are common. Fixed-dose combinations (FDCs) enhance adherence and simplify treatment, bolstered by recent approval of combination formulations in several markets.


Future Market Projections and Trends

Market Growth Drivers

  • Rising Hypertension Prevalence: Globally, over 1.28 billion adults are hypertensive[^1], ensuring sustained demand.
  • Generic Drug Availability: Cost-effective generics continue to facilitate widespread use, especially in developing economies.
  • Expanding Use in Comorbid Conditions: Use in diabetic nephropathy, heart failure, and resistant hypertension broadens market prospects.
  • Regulatory Support for Fixed-Dose Combinations: FDCs incorporating HCTZ or quinapril are expected to boost adherence and sales.

Challenges and Opportunities

  • Safety Concerns: Emerging safety data and competing agents with better long-term safety profiles could diminish market share for HCTZ and quinapril.
  • New Therapeutics: The advent of ARNIs (angiotensin receptor-neprilysin inhibitors) and SGLT2 inhibitors provide alternative treatment options, potentially impacting demand.
  • Digital Health & Personalized Medicine: Pharmacogenomic insights may refine patient selection, enhancing drug efficacy and safety.

Projections (2023-2030):

  • Hydrochlorothiazide: Market share expected to decline modestly, from approximately 30% of diuretic sales to around 20%, as newer agents gain prominence.
  • Quinapril Hydrochloride: Slight decline anticipated in monotherapy use, but sustained demand in combination therapies and specific indications. Market value projected to remain stable, with a CAGR of 2-3%.

Conclusion

Hydrochlorothiazide and quinapril hydrochloride continue to serve vital roles in hypertension management amidst evolving clinical evidence and market dynamics. While safety concerns and emerging therapeutics shape their trajectory, their affordability, familiarity, and proven efficacy sustain their relevance. Ongoing clinical trials expanding understanding of their broader applications and safety profiles are critical to optimizing their clinical utility. Manufacturers, healthcare providers, and policymakers must navigate safety concerns, competitive pressures, and technological innovations to maximize these drugs' therapeutic and commercial potential.


Key Takeaways

  • Clinical trials over recent years reinforce the efficacy of HCTZ and quinapril but highlight gaps that prompt further research, particularly regarding safety and long-term outcomes.
  • Market analysis indicates steady demand worldwide, driven by high hypertension prevalence, with a gradual transition towards newer agents and combination therapies.
  • Generics dominate the market, especially in emerging regions, though competition from novel medications and formulations pose challenges.
  • Future growth hinges on addressing safety concerns, expanding indications, and leveraging fixed-dose combinations to improve adherence.
  • Strategic investments in clinical research, formulation innovation, and market expansion will be crucial for maintaining competitiveness.

FAQs

  1. Are hydrochlorothiazide and quinapril hydrochloride still considered first-line treatments for hypertension?
    Yes, they are widely used, especially in combination therapies, although newer agents with improved safety profiles are increasingly preferred in certain guidelines.

  2. What are the main safety concerns associated with these drugs?
    Hydrochlorothiazide may cause electrolyte imbalances, metabolic disturbances, and, in rare cases, increased risk of skin cancer. Quinapril can cause angioedema, hyperkalemia, and renal impairment.

  3. How has recent clinical research influenced the use of hydrochlorothiazide?
    Emerging evidence suggests alternative diuretics like chlorthalidone may offer better cardiovascular protection, leading to some shifts in prescribing patterns.

  4. What is the outlook for quinapril hydrochloride in the coming years?
    It should retain use primarily in combination therapies. Its market will likely remain stable given its safety and efficacy, but growth may be limited as newer therapies emerge.

  5. Are there any promising new therapeutics that could replace HCTZ and quinapril?
    Agents like SGLT2 inhibitors, ARNIs, and novel antihypertensives are expanding options, but HCTZ and quinapril will remain relevant due to their low cost and extensive clinical experience.


Sources

[1] World Health Organization. (2022). Hypertension Fact Sheet.

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