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Last Updated: January 8, 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.
NCT00649441 ↗ Fasting 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™ 20 mg/25 mg tablets following a single, oral 20 mg/25 mg (1 x 20 mg/25 mg) dose administered under fasting 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
Type 2 Diabetes Mellitus 1
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Condition MeSH

Condition MeSH for HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Intervention Trials
Hypertension 2
Diabetes Mellitus, Type 2 1
Diabetes Mellitus 1
Malnutrition 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
India 2
Turkey 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
Pfizer 1
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Sponsor Type

Sponsor Type for HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Sponsor Trials
Industry 6
Other 1
NIH 1
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HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE Market Analysis and Financial Projection

Hydrochlorothiazide and Quinapril Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Hydrochlorothiazide and quinapril hydrochloride are two potent medications often combined to treat hypertension. This article delves into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Safety and Efficacy

Clinical trials have extensively evaluated the safety and efficacy of quinapril and hydrochlorothiazide when used together. In studies involving 1571 patients, including 943 patients in controlled studies, the combination was found to be effective in lowering blood pressure with a favorable safety profile[1][4].

Adverse Events

The most common adverse events reported in these trials included headache (6.7%), dizziness (4.8%), cough (3.2%), and fatigue (2.9%). Serious adverse events, such as hematemesis, gout, syncope, and angioedema, were observed in less than 0.2% of patients. Therapy was discontinued in 2.1% of patients due to adverse events, with headache and dizziness being the most frequent reasons[1].

Pharmacokinetics and Pharmacodynamics

The combination of quinapril and hydrochlorothiazide does not alter the absorption rates of the individual components compared to monotherapy. Quinapril is deesterified to its active metabolite, quinaprilat, which has a half-life of approximately 3 hours. Hydrochlorothiazide, on the other hand, is not metabolized and has a diuretic effect that begins within 2 hours and lasts for 6 to 12 hours[2].

Market Analysis

Current Market Trends

The market for hydrochlorothiazide is driven by several key factors, including the increasing prevalence of hypertension globally. The rise in the geriatric population and increased awareness for the treatment of heart diseases also contribute to market growth. Additionally, higher healthcare expenditure and ongoing research and development activities by pharmaceutical companies are propelling the market forward[5].

Market Growth Drivers

  • Increasing Prevalence of Hypertension: The global rise in hypertension cases is a significant driver for the hydrochlorothiazide market.
  • Geriatric Population: The increasing age of the population is associated with higher rates of hypertension, thus boosting demand.
  • FDA Approvals and New Product Launches: Continuous approvals and launches of new drugs, including combination therapies like quinapril and hydrochlorothiazide, fuel market growth[5].

Market Challenges

Despite the positive trends, the market faces challenges such as the side effects associated with hydrochlorothiazide. These side effects can include electrolyte imbalances, increased uric acid levels, and other adverse reactions, which may hamper market growth[5].

Market Projections

Future Outlook

The hydrochlorothiazide market is expected to grow significantly over the next decade. The increasing demand for antihypertensive medications, coupled with advancements in pharmaceutical research and development, will drive this growth. Here are some key projections:

  • Market Size: The global hydrochlorothiazide market is anticipated to expand due to the rising incidence of hypertension and the growing need for effective antihypertensive treatments.
  • Geographical Expansion: Emerging markets, particularly in regions with rapidly aging populations, are expected to contribute significantly to the market growth.
  • Innovative Formulations: The development of new formulations and combination therapies, such as quinapril and hydrochlorothiazide, will continue to play a crucial role in market expansion[5].

Clinical Significance and Therapeutic Benefits

Blood Pressure Management

The combination of quinapril and hydrochlorothiazide offers a synergistic effect in lowering blood pressure, which is greater than that achieved with either agent alone. This is particularly beneficial in managing hypertension, as it reduces the risk of fatal and nonfatal cardiovascular events, such as strokes and myocardial infarctions[2].

Comprehensive Cardiovascular Risk Management

Control of high blood pressure is part of a comprehensive cardiovascular risk management strategy that includes lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. The use of quinapril and hydrochlorothiazide aligns with these guidelines, making it a valuable treatment option[2].

Expert Insights

Quinapril's Potency

"Quinapril has been found to be the most potent of all available ACE inhibitors in binding to tissue ACE, which may contribute to its potent and sustained duration of action," notes a study on the clinical development of quinapril. This potency makes quinapril an effective component in combination therapy for hypertension[3].

Combination Therapy Benefits

"By blocking the renin-angiotensin-aldosterone axis, administration of quinapril tends to reduce the potassium loss associated with the diuretic," highlighting the beneficial interaction between quinapril and hydrochlorothiazide in maintaining serum potassium levels[2].

Key Statistics

  • Patient Enrollment: Clinical trials have involved over 1571 patients, including 943 in controlled studies[1][4].
  • Adverse Event Rates: Therapy was discontinued in 2.1% of patients due to adverse events[1].
  • Market Growth: The global hydrochlorothiazide market is expected to grow significantly due to increasing hypertension prevalence and geriatric population[5].

Illustrative Examples

Real-World Impact

A study cited that the antihypertensive effects of quinapril and hydrochlorothiazide were sustained for at least 24 hours, and increased with increasing doses of either component. This sustained effect is crucial in real-world scenarios where consistent blood pressure control is essential[2].

Clinical Trials Data

"Results of these studies supported the recommendation of a once daily dosage of quinapril, 10-40 mg, as first-line therapy in the management of hypertension, with diuretics as concomitant therapy as required in patients with severe hypertension." - PubMed[3]

Key Takeaways

  • Clinical Efficacy: Quinapril and hydrochlorothiazide combination therapy is highly effective in lowering blood pressure and reducing cardiovascular risks.
  • Market Growth: The market for hydrochlorothiazide is expected to grow due to increasing hypertension prevalence, geriatric population, and advancements in pharmaceutical research.
  • Safety Profile: The combination has a favorable safety profile, although it is associated with some common adverse events like headache and dizziness.
  • Therapeutic Benefits: The therapy offers comprehensive cardiovascular risk management by reducing potassium loss and providing sustained antihypertensive effects.

FAQs

What is the primary indication for Quinapril and Hydrochlorothiazide Tablets?

The primary indication for Quinapril and Hydrochlorothiazide Tablets is the treatment of hypertension to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events[2].

What are the most common adverse events associated with Quinapril and Hydrochlorothiazide?

The most common adverse events include headache, dizziness, cough, and fatigue. Serious adverse events such as hematemesis, gout, syncope, and angioedema are rare[1].

How does the combination of Quinapril and Hydrochlorothiazide affect serum potassium levels?

The combination tends to reduce the potassium loss associated with hydrochlorothiazide, maintaining near-zero average changes in serum potassium levels when used together[2].

What is the expected market growth for Hydrochlorothiazide?

The market for hydrochlorothiazide is expected to grow significantly due to the increasing prevalence of hypertension, the growing geriatric population, and advancements in pharmaceutical research and development[5].

Are there any specific populations where the efficacy of Quinapril and Hydrochlorothiazide may vary?

The efficacy of quinapril monotherapy is somewhat less effective in black patients compared to non-black patients, but the combination therapy appears to be effective regardless of race[2].

Sources

  1. Quinapril and Hydrochlorothiazide Tablets. Health Canada. Retrieved 2022-12-13.
  2. Quinapril and Hydrochlorothiazide: Package Insert / Prescribing Info. Drugs.com. Updated 2024-02-04.
  3. Overview of the clinical development of quinapril. PubMed. Retrieved 2189616.
  4. ACCURETIC® (quinapril HCl, hydrochlorothiazide) Patient information. Pfizer Medical Information.
  5. Hydrochlorothiazide Market Size | Industry Growth, (2021-2030). Allied Market Research.

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