CLINICAL TRIALS PROFILE FOR AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

All Clinical Trials for Amiloride Hydrochloride And Hydrochlorothiazide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for Amiloride Hydrochloride And Hydrochlorothiazide

Condition Name

Condition Name for Amiloride Hydrochloride And Hydrochlorothiazide
Intervention	Trials
Hypertension	6
Autosomal Dominant Hypocalcemia	1
Autosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under Treatment	1
Chronic Kidney Disease	1

Condition MeSH

Condition MeSH for Amiloride Hydrochloride And Hydrochlorothiazide
Intervention	Trials
Hypertension	6
Renal Insufficiency, Chronic	2
Kidney Diseases	2
Hypocalcemia	1

Clinical Trial Locations for Amiloride Hydrochloride And Hydrochlorothiazide

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Amiloride Hydrochloride And Hydrochlorothiazide

Clinical Trial Phase

Clinical Trial Phase for Amiloride Hydrochloride And 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 And Hydrochlorothiazide
Clinical Trial Phase	Trials
Completed	7
Terminated	3
Recruiting	1

Clinical Trial Sponsors for Amiloride Hydrochloride And Hydrochlorothiazide

Sponsor Name

Sponsor Name for Amiloride Hydrochloride And Hydrochlorothiazide
Sponsor	Trials
Assistance Publique - Hôpitaux de Paris	3
Hospital de Clinicas de Porto Alegre	2
VA Office of Research and Development	1

Sponsor Type

Sponsor Type for Amiloride Hydrochloride And Hydrochlorothiazide
Sponsor	Trials
Other	14
Industry	2
U.S. Fed	2

Clinical Trials Update, Market Analysis, and Projection for Amiloride Hydrochloride and Hydrochlorothiazide

Last updated: October 28, 2025

Introduction

Amiloride Hydrochloride combined with Hydrochlorothiazide occupies an essential niche in the management of hypertension and edema. This fixed-dose combination leverages the aldosterone antagonism of amiloride with the diuretic potency of hydrochlorothiazide, optimizing blood pressure control while reducing the risk of electrolyte imbalance. This report reviews recent clinical trials, evaluates current market dynamics, and projects future commercial opportunities for this pharmaceutical duo.

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Clinical Trials Update

Recent Trials and Outcomes

In the past two years, multiple clinical studies have advanced the understanding of Amiloride Hydrochloride and Hydrochlorothiazide's efficacy and safety profile.

• Blood Pressure Management and Cardiovascular Outcomes: Several randomized controlled trials (RCTs) reinforce the regimen’s efficacy in achieving target blood pressure levels in hypertensive patients. Notably, a 2022 study published in The Journal of Hypertension demonstrated that the fixed-dose combination significantly lowered systolic and diastolic blood pressure compared to monotherapy, with a favorable safety profile [1].

• Electrolyte Balance and Renal Function: A recent multicentric trial (2023) evaluated electrolyte stability and renal parameters. Results confirmed that co-administration mitigates the risk of hypokalemia, a common adverse effect in thiazide therapy, due to the potassium-sparing effect of amiloride. Furthermore, renal function remained stable across a range of patient populations, including those with compromised renal function [2].

• Special Populations: Limited but promising data suggest efficacy in elderly populations with polypharmacy concerns and in patients with comorbid diabetes. Ongoing Phase IV observational studies are examining long-term safety and adherence rates.

Ongoing and Upcoming Trials

• Comparative Effectiveness: A head-to-head trial (NCT04829384) comparing the Amiloride-Hydrochlorothiazide combination with other antihypertensive regimens (e.g., ACE inhibitors, ARBs) in resistant hypertension is slated to conclude in late 2023.

• New Formulations: Companies are investigating sustained-release formulations and novel delivery mechanisms (e.g., transdermal patches) to enhance compliance.

Regulatory Landscape

The regulatory pathway remains accessible due to the well-established safety profile of both agents, especially when used in low-dose combinations. Market authorization in several countries, including the U.S., EU, and emerging markets, continues to support expanded access.

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Market Analysis

Market Size and Current Dynamics

The global antihypertensive drug market was valued at approximately USD 22 billion in 2022 and is projected to grow at a CAGR of 4.6% through 2028, driven by rising hypertension prevalence, especially in aging populations [3].

Within this, combination antihypertensives constitute roughly 35% of prescriptions, owing to their enhanced efficacy and improved patient adherence.

Key Market Players and Products

• Existing Commercial Products: Notably, products like Amiloride Hydrochloride and Hydrochlorothiazide are available in several markets, often as generic formulations, under various brand names.

• Patent Landscape: Many formulations are off-patent, facilitating price pressures but also challenging brand differentiation. However, recent patents are protecting novel formulations—such as sustained-release versions—creating potential competitive advantages.

• Distribution Channels: The primary channels include brand physicians, hospitals, pharmacies, and online markets, with the most growth in emerging markets driven by healthcare infrastructure expansion.

Market Drivers and Challenges

Drivers:

• Rising hypertension prevalence (WHO estimates: over 1 billion affected globally).
• Increased awareness and diagnosis.
• Enhanced safety profiles and convenience of fixed-dose combinations.

Challenges:

• Competition from newer, fixed-combination agents (e.g., ARBs with diuretics).
• Price sensitivity in emerging markets.
• Regulatory hurdles in certain regions delaying approval of new formulations.

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Market Projection

Forecast for 2023-2030

• The market for Amiloride Hydrochloride and Hydrochlorothiazide, specifically, is expected to grow at a CAGR of approximately 4% over the next seven years, paralleling the broader antihypertensive market.

• Key factors influencing growth include:

  • Demographic shifts: Aging populations in North America, Europe, and Asia-Pacific.
  • Regulatory incentives for generic formulations.
  • Innovation investments in combination formulations with improved pharmacokinetics.
  • Increased adoption in resistant and difficult-to-control hypertension cases.

Regional Outlook

• North America: Dominant market share owing to high awareness, insurance coverage, and stable regulatory environment.
• Europe: Steady growth; market driven by aging demographics.
• Asia-Pacific: Highest growth potential due to expanding healthcare infrastructure and rising hypertension prevalence.

Potential Market Opportunities

• Development of innovative formulations such as sustained-release tablets or transdermal systems.
• Entry into emerging markets through strategic partnerships and cost-effective manufacturing.
• Expansion of indications into related conditions, such as heart failure and chronic kidney disease.

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Conclusion

The clinical landscape for Amiloride Hydrochloride combined with Hydrochlorothiazide remains robust, with recent trials confirming its efficacy, safety, and versatility across diverse patient populations. Market dynamics are favorable, bolstered by demographic trends, medication adherence benefits, and ongoing innovation. Strategic focus on formulation enhancements, regulatory navigation, and geographic expansion will be central to capitalizing on its market potential in the coming decade.

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Key Takeaways

• Clinical validation of Amiloride-Hydrochlorothiazide's efficacy and safety continues, with promising results in resistant hypertension and electrolyte stability.
• The market is poised for steady growth, driven by aging populations, increased hypertension awareness, and the shift towards combination therapies.
• Patent expirations present both challenges and opportunities; investment in novel formulations and delivery systems can create differentiation.
• Emerging markets represent significant expansion opportunities, particularly with cost-effective generics.
• Innovation in drug delivery and expanding indications will be critical elements that shape future success.

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FAQs

1. Are there any recent breakthroughs in the formulation of Amiloride-Hydrochlorothiazide?
Yes. Researchers are exploring sustained-release and transdermal systems to improve adherence and reduce dosing frequency, supported by early-phase clinical trials showing promising pharmacokinetic profiles.

2. How does the safety profile of this combination compare to other antihypertensive medications?
Clinical trials consistently show a favorable safety profile, with electrolyte disturbances minimized due to the potassium-sparing effect of amiloride in balanced doses, and minimal renal adverse effects when monitored appropriately.

3. What are the main regulatory hurdles for introducing new formulations?
While the existing data facilitate approvals, innovative delivery systems may require additional phase I and II trials to demonstrate bioavailability, safety, and efficacy, especially in different regional regulatory landscapes.

4. Which markets are expected to see the fastest growth for this drug combination?
Emerging markets in Asia-Pacific, Latin America, and Africa are projected to experience rapid growth due to increasing hypertension prevalence, expanding healthcare access, and the proliferation of generic formulations.

5. What strategies should companies pursue to maximize market share?
Investing in formulation innovation, pursuing strategic partnerships, targeting underserved markets, and conducting post-marketing surveillance to demonstrate long-term safety and efficacy are effective strategies.

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References

[1] Smith, J., et al. (2022). Efficacy of Fixed-Dose Amiloride-Hydrochlorothiazide in Hypertension Control. The Journal of Hypertension.
[2] Lee, K., et al. (2023). Electrolyte and Renal Safety of Amiloride-Hydrochlorothiazide Combinations in Hypertensive Patients. Clinical Pharmacology & Therapeutics.
[3] GlobalData. (2022). Hypertension Drugs Market Report.