CLINICAL TRIALS PROFILE FOR AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

All Clinical Trials for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.

Clinical Trial Conditions for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Condition Name

Condition Name for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Intervention	Trials
Hypertension	6
Chronic Kidney Diseases	1
Dent's Disease	1
Nephrolithiasis	1

Condition MeSH

Condition MeSH for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Intervention	Trials
Hypertension	6
Renal Insufficiency, Chronic	2
Kidney Diseases	2
Proteinuria	1

Clinical Trial Locations for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Trials by Country

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Trials by Country for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Location	Trials
United States	11
France	4
Brazil	2
Mexico	1
South Africa	1

Trials by US State

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−

Trials by US State for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Location	Trials
Virginia	1
Tennessee	1
Pennsylvania	1
Ohio	1
Mississippi	1

Clinical Trial Progress for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Clinical Trial Phase

Clinical Trial Phase for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Clinical Trial Phase	Trials
Completed	7
Terminated	3
Unknown status	1

Clinical Trial Sponsors for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Sponsor Name

Sponsor Name for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Sponsor	Trials
Assistance Publique - Hôpitaux de Paris	3
Hospital de Clinicas de Porto Alegre	2
GlaxoSmithKline	1

Sponsor Type

Sponsor Type for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Sponsor	Trials
Other	14
Industry	2
U.S. Fed	2

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

Introduction

Amiloride hydrochloride and hydrochlorothiazide are two diuretic drugs often combined to treat conditions such as congestive heart failure, high blood pressure (hypertension), and edema. This article will delve into the clinical trials, market analysis, and future projections for these medications.

Clinical Trials Overview

Completed Trials

One notable clinical trial involving amiloride hydrochloride and hydrochlorothiazide is the comparison of antihypertensive therapy with triamterene-hydrochlorothiazide versus amiloride-hydrochloride-hydrochlorothiazide. This study, published in the Archives of Internal Medicine, compared the effects of these diuretic combinations on renal prostaglandin E2 excretion. The results showed that therapy with amiloride-hydrochlorothiazide enhanced renal PGE2 production, whereas triamterene-hydrochlorothiazide decreased it[4].

Ongoing and Past Studies

Another study listed in the EU Clinical Trials Register involved a double-blind, placebo-controlled, cross-over trial with approximately 66 patients. This trial, sponsored by an unspecified entity, was completed but the specific outcomes are not detailed in the available summary[3].

Mechanism of Action and Pharmacology

Amiloride Hydrochloride

Amiloride hydrochloride is a potassium-sparing diuretic that works by inhibiting the sodium channels in the collecting ducts of the kidneys, thereby reducing sodium reabsorption and potassium secretion. It is not metabolized by the liver and is primarily excreted unchanged in the urine and stool[5].

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic that affects the renal tubular mechanism of electrolyte reabsorption, increasing the excretion of sodium and chloride. When combined with amiloride hydrochloride, it enhances the diuretic and antihypertensive effects while minimizing potassium loss and the risk of acid-base imbalance[5].

Market Analysis

Current Market Trends

The market for hydrochlorothiazide, and by extension amiloride hydrochloride when used in combination, is driven by several key factors:

• Increasing Prevalence of Hypertension: The rising number of patients suffering from hypertension globally is a significant driver for the market growth of these diuretics[2].
• Geriatric Population: The increase in the geriatric population, who are more prone to hypertension and other cardiovascular diseases, also boosts market growth[2].
• Healthcare Expenditure: Increased healthcare expenditure and awareness for the treatment of heart diseases further fuel the market[2].

Market Growth Projections

The hydrochlorothiazide market, which includes combinations with amiloride hydrochloride, is expected to grow significantly due to:

• New Product Launches: The introduction of novel drugs and combinations is anticipated to flourish the market[2].
• Research and Development: Continuous research and development activities by pharmaceutical companies are expected to propel market growth[2].
• COVID-19 Impact: Although not directly related to COVID-19, the overall increase in healthcare demand and research activities during the pandemic has indirectly supported the growth of the pharmaceutical industry, including diuretics[2].

Challenges and Restraints

Side Effects

One of the major restraints on the market growth of hydrochlorothiazide and amiloride hydrochloride is the side effects associated with these medications. Common adverse reactions include hyperkalemia, metabolic acidosis, and gastrointestinal disturbances[1].

Regulatory Considerations

The use of these drugs, especially during pregnancy, is subject to careful consideration due to the lack of adequate and well-controlled studies in pregnant women. Animal studies have shown no evidence of harm to the fetus, but human response cannot be guaranteed[1].

Market Size and Share

Competitive Landscape

The market for diuretics, including combinations of amiloride hydrochloride and hydrochlorothiazide, is competitive with several pharmaceutical companies involved. The market share is influenced by factors such as the potency of buyers and suppliers, as analyzed through Porter’s five forces analysis[2].

Quantitative Analysis

The current market is quantitatively analyzed to highlight the growth scenario, with detailed information on key drivers, restraints, and opportunities. This analysis helps in identifying imminent investment pockets and understanding the competitive intensity[2].

Future Projections

Increasing Demand

The demand for diuretics like amiloride hydrochloride and hydrochlorothiazide is expected to increase due to the rising prevalence of hypertension and other cardiovascular diseases. This trend is likely to continue, driven by demographic changes and increased healthcare expenditure[2].

Innovations and New Launches

The market is expected to benefit from new product launches and innovative combinations of existing drugs. Pharmaceutical companies are continuously working on developing novel treatments that address the side effects and efficacy of current diuretics[2].

Key Takeaways

• Clinical Trials: Studies have shown that amiloride-hydrochlorothiazide combinations are effective and have distinct renal effects compared to other diuretic combinations.
• Market Drivers: The market is driven by increasing hypertension prevalence, geriatric population growth, and increased healthcare expenditure.
• Challenges: Side effects and regulatory considerations are significant restraints on market growth.
• Future Projections: The market is expected to grow due to increasing demand, new product launches, and ongoing research and development.

FAQs

What is the primary use of amiloride hydrochloride and hydrochlorothiazide?

The primary use of amiloride hydrochloride and hydrochlorothiazide is in the treatment of conditions such as congestive heart failure, high blood pressure (hypertension), and edema, particularly in patients where maintaining normal potassium levels is crucial.

How do amiloride hydrochloride and hydrochlorothiazide work together?

Amiloride hydrochloride and hydrochlorothiazide work together by combining the potassium-sparing action of amiloride with the natriuretic and diuretic actions of hydrochlorothiazide, minimizing potassium loss and reducing the risk of acid-base imbalance.

What are the common side effects of amiloride hydrochloride and hydrochlorothiazide?

Common side effects include hyperkalemia, metabolic acidosis, gastrointestinal disturbances, and other electrolyte imbalances.

Can amiloride hydrochloride and hydrochlorothiazide be used during pregnancy?

These drugs should be used during pregnancy only if clearly needed, as there are no adequate and well-controlled studies in pregnant women, although animal studies have shown no evidence of harm to the fetus[1].

What is the expected market growth for hydrochlorothiazide and amiloride hydrochloride combinations?

The market is expected to grow significantly due to increasing demand for hypertension treatment, new product launches, and ongoing research and development activities in the pharmaceutical industry[2].

Sources

1. RxList: Amiloride Hydrochloride - RxList
2. Allied Market Research: Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)
3. EU Clinical Trials Register: 2007-005655-42
4. JAMA Network: Antihypertensive Therapy With Triamterene-Hydrochlorothiazide vs Amiloride-Hydrochlorothiazide
5. Health Canada: Amiloride Hydrochloride and Hydrochlorothiazide Tablets