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Last Updated: May 22, 2025

CLINICAL TRIALS PROFILE FOR QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE


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All Clinical Trials for Quinapril Hydrochloride And Hydrochlorothiazide

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 Accureticâ„¢ 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' Accureticâ„¢ 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 Quinapril Hydrochloride And Hydrochlorothiazide

Condition Name

Condition Name for Quinapril Hydrochloride And Hydrochlorothiazide
Intervention Trials
Healthy 4
Hypertension 2
Metabolic Syndrome X 1
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Condition MeSH

Condition MeSH for Quinapril Hydrochloride And Hydrochlorothiazide
Intervention Trials
Hypertension 2
Malnutrition 1
Metabolic Syndrome X 1
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Clinical Trial Locations for Quinapril Hydrochloride And Hydrochlorothiazide

Trials by Country

Trials by Country for Quinapril Hydrochloride And Hydrochlorothiazide
Location Trials
United States 3
Turkey 2
India 2
Romania 1
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Trials by US State

Trials by US State for Quinapril Hydrochloride And Hydrochlorothiazide
Location Trials
North Dakota 2
Tennessee 1
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Clinical Trial Progress for Quinapril Hydrochloride And Hydrochlorothiazide

Clinical Trial Phase

Clinical Trial Phase for Quinapril Hydrochloride And Hydrochlorothiazide
Clinical Trial Phase Trials
Phase 4 3
Phase 1 2
N/A 2
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Clinical Trial Status

Clinical Trial Status for Quinapril Hydrochloride And Hydrochlorothiazide
Clinical Trial Phase Trials
Completed 7
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Clinical Trial Sponsors for Quinapril Hydrochloride And Hydrochlorothiazide

Sponsor Name

Sponsor Name for Quinapril Hydrochloride And Hydrochlorothiazide
Sponsor Trials
Mylan Pharmaceuticals 2
Ranbaxy Laboratories Limited 2
LaborMed Pharma S.A. 1
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Sponsor Type

Sponsor Type for Quinapril Hydrochloride And Hydrochlorothiazide
Sponsor Trials
Industry 6
NIH 1
Other 1
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Quinapril Hydrochloride and Hydrochlorothiazide: A Comprehensive Overview

Introduction

Quinapril hydrochloride and hydrochlorothiazide is a fixed-combination medication used primarily for the treatment of hypertension. This article will delve into the clinical trials, pharmacokinetics, market analysis, and projections for this drug combination.

Clinical Trials and Efficacy

Hypertension Management

Clinical trials have demonstrated the efficacy of quinapril and hydrochlorothiazide in managing hypertension. Studies involving 1571 patients with essential hypertension showed that the combination therapy provided a significant blood pressure lowering effect greater than that seen with either agent alone[3].

Dose-Response Relationship

In clinical trials using quinapril doses of 2.5 to 40 mg and hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects were sustained for at least 24 hours and increased with increasing doses of either component[2][3].

Racial Differences in Efficacy

It is noted that quinapril monotherapy is somewhat less effective in black patients than in non-black patients. However, the efficacy of the combination therapy appears to be independent of race[2][3].

Potassium Levels

The combination of quinapril and hydrochlorothiazide tends to reduce the potassium loss associated with diuretic use. Clinical trials showed that the average change in serum potassium was near zero when quinapril was combined with hydrochlorothiazide, indicating a protective effect on potassium levels[2][3].

Pharmacokinetics

Absorption

Following oral administration, peak plasma quinapril concentrations are observed within 1 hour, with an extent of absorption of at least 60%. Hydrochlorothiazide absorption is somewhat slower (1 to 2.5 hours) but more complete (50% to 80%)[1][2].

Metabolism and Elimination

Quinapril is deesterified to its major active metabolite, quinaprilat, which is eliminated primarily by renal excretion. Hydrochlorothiazide is excreted unchanged by the kidney. The elimination half-life of quinaprilat is approximately 2 hours with a prolonged terminal phase, while hydrochlorothiazide's plasma half-life varies between 4 to 15 hours[1][2].

Adverse Reactions and Safety

Common Adverse Events

The most frequent adverse experiences in controlled trials include headache (6.7%), dizziness (4.8%), cough (3.2%), and fatigue (2.9%). The cough is characteristically non-productive and resolves after discontinuation of therapy[3].

Serious Adverse Events

Serious or clinically significant adverse reactions observed in less than 0.2% of patients include hematemesis, gout, syncope, and angioedema. Therapy was discontinued in 2.1% of patients due to an adverse event[3].

Market Analysis

Market Growth Drivers

The market for quinapril and hydrochlorothiazide is driven by several factors:

  • Increasing Prevalence of Hypertension: The global rise in hypertension cases is a significant driver, as more patients require effective antihypertensive medications[5].
  • Geriatric Population: The increasing geriatric population, which is more prone to hypertension, fuels the demand for this medication[5].
  • Healthcare Expenditure: Rising healthcare expenditure and increased awareness for heart disease treatment also contribute to market growth[5].

Market Trends

  • New Product Launches: The launch of novel formulations and combination therapies is expected to flourish the market.
  • Research and Development: Ongoing research and development activities by pharmaceutical companies are likely to introduce more effective and safer versions of the drug[5].

Challenges

Despite the growth drivers, the market faces challenges such as side effects associated with hydrochlorothiazide, which can hamper market growth. Common side effects include electrolyte imbalances, increased urination, and dizziness[5].

Market Projections

Future Outlook

The hydrochlorothiazide market, which includes combination therapies like quinapril and hydrochlorothiazide, is expected to grow significantly from 2021 to 2030. This growth is attributed to the increasing number of patients suffering from hypertension, the rise in the geriatric population, and increased healthcare expenditure[5].

Global Impact

The global hydrochlorothiazide market is influenced by factors such as the COVID-19 pandemic, which has highlighted the importance of robust healthcare systems and the need for effective medications. This has led to increased investment in pharmaceutical research and development, further propelling market growth[5].

Key Takeaways

  • Efficacy: Quinapril and hydrochlorothiazide combination therapy is highly effective in managing hypertension, with sustained antihypertensive effects.
  • Pharmacokinetics: The drug combination has favorable absorption and elimination profiles, making it suitable for once-daily dosing.
  • Safety: Common adverse events include headache, dizziness, and cough, while serious adverse events are rare.
  • Market Growth: The market is driven by increasing hypertension prevalence, geriatric population growth, and rising healthcare expenditure.
  • Challenges: Side effects associated with hydrochlorothiazide can hamper market growth.

FAQs

What is the primary indication for quinapril and hydrochlorothiazide?

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

How does the combination of quinapril and hydrochlorothiazide affect potassium levels?

The combination tends to reduce the potassium loss associated with diuretic use, with the average change in serum potassium being near zero in clinical trials[2][3].

What are the common adverse events associated with quinapril and hydrochlorothiazide?

Common adverse events include headache, dizziness, cough, and fatigue. The cough is characteristically non-productive and resolves after discontinuation of therapy[3].

How does food intake affect the absorption of quinapril and hydrochlorothiazide?

The rate of absorption of both quinapril and hydrochlorothiazide is reduced when administered with a high-fat meal, but the extent of absorption remains unaffected. Therefore, the medication can be taken without regard to food[1][2].

What are the market growth drivers for quinapril and hydrochlorothiazide?

The market growth is driven by the increasing prevalence of hypertension, the rise in the geriatric population, and increased healthcare expenditure[5].

Sources

  1. Accuretic (quinapril HCI/hydrochlorothiazide) tablet label. FDA.
  2. Quinapril and Hydrochlorothiazide: Package Insert / Prescribing Info. Drugs.com.
  3. APO-QUINAPRIL/HCTZ. Health Canada.
  4. Hydrochlorothiazide: Uses, Interactions, Mechanism of Action. DrugBank.
  5. Hydrochlorothiazide Market Size | Industry Growth, (2021-2030). Allied Market Research.
Last updated: 2025-01-01

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