CLINICAL TRIALS PROFILE FOR AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

All Clinical Trials for AMILORIDE HYDROCHLORIDE; 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; 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
Kidney Calculi	1

Clinical Trial Locations for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Trials by Country

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

Trials by US State for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Location	Trials
New Mexico	1
Virginia	1
Tennessee	1
Pennsylvania	1
Ohio	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
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	1

Sponsor Type

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

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

Last updated: February 21, 2026

What is the current status of clinical trials for Amiloride Hydrochloride combined with Hydrochlorothiazide?

Amiloride Hydrochloride and Hydrochlorothiazide combination medication targets hypertension and edema management. As of Q1 2023, no new Phase III clinical trials are publicly registered for this specific combination. Most research efforts focus on these compounds' individual efficacy or repurposed use for resistant hypertension or heart failure. Existing trials include:

• Blood pressure reduction studies involving hydrochlorothiazide monotherapy.
• Diuretic efficacy assessments for amiloride in resistant cases.
• Combination therapy trials with other antihypertensives, involving smaller, early-stage studies.

Major registries, including ClinicalTrials.gov, list no ongoing large-scale trials for the combination, suggesting the compound's market approval remains based on prior established trials or off-label use.

How has the market for this combination evolved?

Market Overview

The combined use of amiloride and hydrochlorothiazide has existed as an off-label formulary, with several branded and generic options.

Parameter	Data
Global antihypertensive market size (2022)	USD 40.3 billion
Diuretic segment share (2022)	Approx. 12% (~USD 4.8 billion)
Amiloride-based drugs market share	Small, <USD 50 million
Hydrochlorothiazide sales	Approx. USD 100 million globally

The combination's sales are driven primarily by generic formulations available since the 1990s. Patent barriers are minimal, with no extended exclusivity. Current formulations target adult hypertensive and edema patients with moderate to severe disease.

Key Product Approvals

• Approved in the U.S. through FDA under generic status.
• Widely used in Europe, with similar regulatory approvals.
• No recent approvals or clinical modifications reported by major pharmaceutical companies.

Competitive Landscape

Main competitors include other diuretics and combination pills like:

• Amlodipine/valsartan.
• Furosemide combinations.
• Fixed-dose combinations with other antihypertensives.

Generic molecules dominate, with limited branded formulations.

What is the market projection looking forward to 2030?

Drivers

• Rising hypertension prevalence: projected to grow from 1.3 billion affected globally in 2020 to 1.6 billion by 2030.
• Increased awareness of resistant hypertension requiring combination therapies.
• Existing generic formulations' low price points support continued usage.

Challenges

• Alternative drug classes (ARBs, ACE inhibitors, SGLT2 inhibitors) gaining popularity.
• Potential regulatory shifts toward new combination drugs with improved safety profiles.
• Patent expirations for some formulations could pressure prices and margins.

Forecast Summary

Year	Estimated Market Size (USD billion)	Compound Annual Growth Rate (CAGR)	Notes
2023	50	-	Current market size, including all diuretic combinations
2025	55	3.8%	Market stabilizes; generic dominance persists
2030	61	3.4%	Slight growth driven by resistance management and aging populations

The forecast presumes steady but modest growth, mainly from global hypertension management needs and incremental adoption of combination therapies.

Which regulatory and R&D trends impact this drug?

• Trend toward personalized medicine favors targeted therapy, potentially reducing reliance on broad-spectrum diuretics.
• Advances in drug delivery and fixed-dose combinations could alter market share.
• Regulatory agencies continue to favor newer agents with better safety profiles, possibly impacting market share during the next decade.

Key considerations for stakeholders

• No current clinical trial pipeline signals imminent product innovation or reformulation.
• Market remains saturated with generics, limiting profitability unless a novel formulation or indication emerges.
• Controlled markets with established regulatory pathways favor maintaining existing formulations' dominance.

Key Takeaways

• Clinical trials for amiloride and hydrochlorothiazide combination are not active or ongoing at a significant scale.
• The drug combination’s market relies heavily on generic availability and existing established prescriptions.
• The global antihypertensive market grows modestly, with incremental demand for diuretic combinations.
• Future growth prospects depend on resistance management, demographic shifts, and regulatory trends favoring innovative or alternative therapies.
• Market stability favors incumbents unless new clinical data or formulations disrupt current practices.

Frequently Asked Questions

1. Are there any ongoing new clinical trials for this drug combination?

No significant new Phase III or later trials are publicly registered as of early 2023.

2. What are the main competitors in the diuretic class?

Furosemide, chlorthalidone, and newer agents like indapamide.Face to face, hydrochlorothiazide remains a standard but faces competition from novel agents.

3. How does patent expiry impact this drug's market?

Patent expiry for most formulations occurs since the late 1990s, leading to high generic competition and price erosion.

4. Who are the leading manufacturers of this combination?

Most global suppliers are generic producers such as Teva, Mylan, and Sandoz. No recent branded announcements or major R&D investments are noted.

5. What is the future outlook for this drug in hypertensive treatment?

Steady but limited. Growth depends on resistance management and demographic increases in hypertensive populations, with little innovation expected in the near term.

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References

[1] World Health Organization. (2022). Hypertension prevalence and projections.
[2] ClinicalTrials.gov. (2023). Registry entries for diuretic trials.
[3] IQVIA. (2022). Global antihypertensive drugs market report.
[4] FDA. (2023). Approved drug products with therapeutic equivalence evaluations.
[5] European Medicines Agency. (2023). Summary of medicinal products for amiloride and hydrochlorothiazide.