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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE


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All Clinical Trials for Amiloride Hydrochloride And Hydrochlorothiazide

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01804777 ↗ Epithelial Sodium Channel (ENaC) as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes Terminated Dialysis Clinic, Inc. Early Phase 1 2013-03-01 The purpose of this study is to determine with the administration of amiloride, observe an enhanced natriuresis, reduction in blood pressure and weight compared to the administration of hydrochlorothiazide in Type 2 Diabetics.
NCT00224549 ↗ PHARES Study: Management of Resistant Hypertension Completed Assistance Publique - Hôpitaux de Paris Phase 4 2005-04-01 The purpose of this study is to assess the efficacy of two different treatment regimens for treating resistant hypertension previously uncontrolled with at least 3 antihypertensive treatments. The study hypothesis is that these two regimens (one based on increasing diuretics and the other based on increasing renin angiotensin system blockage) may not differ in terms of efficacy.
NCT00394394 ↗ Antihypertensive Effectiveness of the Associations of Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril Completed Hospital de Clinicas de Porto Alegre Phase 2 2005-02-01 The majority of hypertensive patients require antihypertensive associations to control their blood pressure. Most of clinical trials don't compare different associations using Hydrochlorothiazide 25 mg as the standard initial therapy and compare the associations using doses that are not equivalent. This randomized trial where patients and investigators are blinded and compares the effectiveness two associations: Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril.
NCT00638482 ↗ Dose-Dependent Effect of Thiazide in Dent's Disease Hypercalciuria Terminated Assistance Publique - Hôpitaux de Paris Phase 2/Phase 3 2003-07-01 Intrarenal calcifications (nephrocalcinosis) is present in Dent's disease and likely contribute to progression toward renal failure. In order to prevent this complication it is usually proposed to treat affected patients during childhood with high doses of thiazides.
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed US Department of Veterans Affairs 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed VA Office of Research and Development 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for Amiloride Hydrochloride And Hydrochlorothiazide

Condition Name

611100123456HypertensionOptic; Neuritis, With DemyelinationPatients With Fungic InfectionsProteinuria[disabled in preview]
Condition Name for Amiloride Hydrochloride And Hydrochlorothiazide
Intervention Trials
Hypertension 6
Optic; Neuritis, With Demyelination 1
Patients With Fungic Infections 1
Proteinuria 1
[disabled in preview] 0
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Condition MeSH

622100123456HypertensionRenal Insufficiency, ChronicKidney DiseasesDiabetes Mellitus, Type 2[disabled in preview]
Condition MeSH for Amiloride Hydrochloride And Hydrochlorothiazide
Intervention Trials
Hypertension 6
Renal Insufficiency, Chronic 2
Kidney Diseases 2
Diabetes Mellitus, Type 2 1
[disabled in preview] 0
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Clinical Trial Locations for Amiloride Hydrochloride And Hydrochlorothiazide

Trials by Country

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Trials by Country for Amiloride Hydrochloride And Hydrochlorothiazide
Location Trials
United States 11
France 4
Brazil 2
Austria 1
China 1
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Trials by US State

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Trials by US State for Amiloride Hydrochloride And Hydrochlorothiazide
Location Trials
New Mexico 1
Virginia 1
Tennessee 1
Pennsylvania 1
Ohio 1
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Clinical Trial Progress for Amiloride Hydrochloride And Hydrochlorothiazide

Clinical Trial Phase

36.4%9.1%9.1%45.5%011.522.533.544.55Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Amiloride Hydrochloride And Hydrochlorothiazide
Clinical Trial Phase Trials
Phase 4 4
Phase 3 1
Phase 2/Phase 3 1
[disabled in preview] 5
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Clinical Trial Status

58.3%25.0%8.3%8.3%01234567CompletedTerminatedRecruiting[disabled in preview]
Clinical Trial Status for Amiloride Hydrochloride And Hydrochlorothiazide
Clinical Trial Phase Trials
Completed 7
Terminated 3
Recruiting 1
[disabled in preview] 1
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Clinical Trial Sponsors for Amiloride Hydrochloride And Hydrochlorothiazide

Sponsor Name

trials0112233Assistance Publique - Hôpitaux de ParisHospital de Clinicas de Porto AlegreGuangdong Provincial People's Hospital[disabled in preview]
Sponsor Name for Amiloride Hydrochloride And Hydrochlorothiazide
Sponsor Trials
Assistance Publique - Hôpitaux de Paris 3
Hospital de Clinicas de Porto Alegre 2
Guangdong Provincial People's Hospital 1
[disabled in preview] 3
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Sponsor Type

77.8%11.1%11.1%002468101214OtherIndustryU.S. Fed[disabled in preview]
Sponsor Type for Amiloride Hydrochloride And Hydrochlorothiazide
Sponsor Trials
Other 14
Industry 2
U.S. Fed 2
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Clinical Trials, Market Analysis, and Projections for Amiloride Hydrochloride and Hydrochlorothiazide

Introduction

Amiloride hydrochloride and hydrochlorothiazide are commonly used in combination as a diuretic and antihypertensive agent. This article delves into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Efficacy and Trials

Multiclinic Comparison Study

A significant clinical trial comparing amiloride hydrochloride, hydrochlorothiazide, and the combination of both was conducted in 179 patients with mild to moderate essential hypertension. The study, which lasted 12 weeks, showed that all three treatment groups experienced significant reductions in blood pressure. The combination of amiloride and hydrochlorothiazide resulted in the greatest reduction in systolic pressure. Additionally, the study highlighted that amiloride helped conserve potassium levels, which is crucial for patients at risk of hypokalemia[1][4].

Potassium Conservation

The combination therapy demonstrated its efficacy in maintaining optimal potassium levels. Amiloride alone increased serum potassium levels from 4.24 to 4.47 mEq/L, while the combination of amiloride and hydrochlorothiazide resulted in a mean serum potassium level of 3.86 mEq/L, which was significantly different from hydrochlorothiazide alone (3.56 mEq/L)[1][4].

Tolerability and Safety

The drugs were well tolerated, with no drug-related toxic reactions detected during the study. This underscores the safety profile of amiloride hydrochloride and hydrochlorothiazide when used together[1][4].

Market Analysis

Market Size and Growth

The global market for hydrochlorothiazide, a key component of the combination therapy, is expected to grow significantly due to the increasing prevalence of hypertension and other cardiovascular diseases. According to market research, the hydrochlorothiazide market is driven by factors such as the rising geriatric population, increased healthcare expenditure, and the launch of new drugs[2].

Key Drivers

  • Increasing Prevalence of Hypertension: The World Health Organization estimates that 1.13 billion people suffer from hypertension globally, and this number is expected to rise to 29% by 2025, particularly in economically developing nations[2].
  • Growing Healthcare Expenditure: Increased spending on healthcare and research & development activities by pharmaceutical companies are propelling the market growth[2].
  • Demographic and Lifestyle Changes: The rising elderly population and changes in lifestyle contribute to the increased demand for diuretic and antihypertensive medications[3].

Market Trends

  • New Product Launches: Innovations in pharmaceutical formulations and the advent of combination therapies are expected to flourish the market. Technological advancements in drug delivery systems also present new opportunities[3].
  • Emerging Economies: The increasing availability of these medications in emerging economies is another significant trend driving market growth[3].

Market Restraints and Challenges

Side Effects and Regulatory Approvals

Despite the benefits, the market growth is hampered by side effects associated with hydrochlorothiazide, such as hypokalemia, hyponatremia, and increases in BUN levels. Stringent regulatory approvals and potential side effects also pose challenges[2][5].

Generic Competition

The presence of generic competitors intensifies pricing pressures for brand leaders, affecting their profitability. This competition can lead to reduced market share and revenue for branded versions of amiloride hydrochloride and hydrochlorothiazide[3].

Future Projections

Market Opportunities

  • Clinical Research: Conducting clinical research to expand the indications and uses for amiloride hydrochloride can open up new market opportunities. Innovations in packaging technology can improve shelf life and distribution efficiency[3].
  • Licensing Agreements: Entering into licensing agreements for local manufacturing can reduce costs and enhance market responsiveness, making the drug more accessible in various regions[3].

Technological Innovations

Technological advancements in drug delivery systems and the development of novel formulations are expected to drive the market forward. These innovations can improve the efficacy and safety profile of the combination therapy[3].

Key Applications and End-Users

Therapeutic Uses

Amiloride hydrochloride and hydrochlorothiazide are primarily used in the management of:

  • Hypertension: To reduce blood pressure and maintain normal potassium levels.
  • Congestive Heart Failure: To combat fluid retention and edema.
  • Hepatic Cirrhosis: To manage ascites and edema with minimal potassium loss[5].

End-User Segments

The main end-use areas include hospitals, clinics, and home healthcare settings. The expanding healthcare infrastructure and patient preference for home-based treatments are driving the demand in these segments[3].

Conclusion

The combination of amiloride hydrochloride and hydrochlorothiazide has proven efficacy in clinical trials as a diuretic and antihypertensive agent, particularly in conserving potassium levels. The market for this combination is expected to grow driven by the increasing prevalence of hypertension, rising healthcare expenditure, and technological innovations. However, it faces challenges from side effects, regulatory approvals, and generic competition.

Key Takeaways

  • Clinical Efficacy: The combination therapy is effective in reducing blood pressure and conserving potassium levels.
  • Market Growth: Driven by increasing hypertension prevalence, healthcare expenditure, and technological innovations.
  • Challenges: Side effects, regulatory approvals, and generic competition.
  • Future Opportunities: Clinical research, licensing agreements, and technological innovations.

FAQs

Q: What are the primary uses of amiloride hydrochloride and hydrochlorothiazide?

A: These drugs are primarily used to manage hypertension, congestive heart failure, and hepatic cirrhosis with ascites and edema.

Q: How does the combination of amiloride and hydrochlorothiazide affect potassium levels?

A: The combination helps conserve potassium levels, with amiloride increasing serum potassium levels and mitigating the potassium loss associated with hydrochlorothiazide.

Q: What are the key drivers of the hydrochlorothiazide market?

A: The market is driven by the increasing prevalence of hypertension, growing healthcare expenditure, and the launch of new drugs.

Q: What challenges does the market for amiloride hydrochloride and hydrochlorothiazide face?

A: The market faces challenges from side effects, stringent regulatory approvals, and generic competition.

Q: What future opportunities exist for the market of amiloride hydrochloride and hydrochlorothiazide?

A: Opportunities include conducting clinical research to expand indications, entering licensing agreements for local manufacturing, and leveraging technological innovations in drug delivery systems.

Sources

  1. Multiclinic Diuretic Cooperative Study Group. Multiclinic Comparison of Amiloride, Hydrochlorothiazide, and Hydrochlorothiazide Plus Amiloride in Essential Hypertension. Arch Intern Med. 1981;141(4):482–486. doi:10.1001/archinte.1981.00340040078021
  2. Allied Market Research. Hydrochlorothiazide Market Size | Industry Growth, (2021-2030).
  3. 360 Research Reports. Amiloride Hydrochloride Tablets Market Size 2025-2030.
  4. PubMed. Multiclinic comparison of amiloride, hydrochlorothiazide ...
  5. Health Canada. Amiloride Hydrochloride and Hydrochlorothiazide Tablets.

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