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.
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.
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.
NCT01804777 ↗	Epithelial Sodium Channel (ENaC) as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes	Terminated	University of Pittsburgh	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.

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
Congenital Abnormalities	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
Puerto Rico	1
Netherlands	1

Trials by US State

Trials by US State for AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Location	Trials
Indiana	1
Florida	1
District of Columbia	1
California	1
New Mexico	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
Erasmus Medical Center	1

Sponsor Type

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

Amiloride Hydrochloride and Hydrochlorothiazide: Clinical-Trials Update, Market Read-Through, and Forecast Framework

Last updated: April 28, 2026

What is the drug and where does it sit in current therapy?

Amiloride hydrochloride and hydrochlorothiazide is a fixed-dose combination (FDC) of:

• Hydrochlorothiazide (HCTZ): thiazide diuretic used for hypertension and edema.
• Amiloride hydrochloride: potassium-sparing diuretic that reduces potassium loss from thiazides.

In practice, the combination is positioned for:

• Hypertension where thiazide therapy is used but hypokalemia risk is a concern.
• Diuretic-associated electrolyte management (potassium preservation) in patients on thiazide-based regimens.

This is a long-established, off-patent class profile in most major markets, with commercial outcomes driven more by formulary access, generics, and payer preference than by novel clinical differentiation.

What does the clinical-trials pipeline look like now?

No complete, time-bound, publicly verifiable “trial-status” set (start dates, phase, endpoints, recruitment status, and active sites) is available in the information provided for this request. Under the analysis constraints, a complete and accurate clinical-trials update cannot be produced from the supplied inputs.

Clinical-trials update (status)

• Active registration and pipeline visibility: not determinable from provided inputs.
• Phase allocation and near-term readouts: not determinable from provided inputs.
• Geographic focus and enrollment: not determinable from provided inputs.

What can be stated as a facts-only profile

The combination’s modern “pipeline” activity in most jurisdictions typically consists of:

• Bioequivalence and formulation trials for FDC products (often generic).
• Comparative tolerability studies related to electrolytes rather than new clinical endpoints.

But those claims require trial-level sourcing, which is not present in the provided information.

How large is the market, and what is the likely commercial structure?

A precise current-market size and forecast require sourcing the reference market and product segment definitions (e.g., “diuretics for hypertension,” “thiazide diuretics combinations,” or “potassium-sparing diuretics combinations”). The request provides no market-sizing dataset, therefore a complete and accurate market analysis cannot be produced under the constraints.

Market structure typically seen for this combination class (decision-relevant)

Given the age of the compounds and typical regulatory reality across major markets, the commercial structure is usually:

• Dominant generic penetration for FDC products where patents have expired.
• Competition via:
  • Price (wholesale acquisition cost and payer negotiated rates)
  • Formulary placement
  • Switching costs (electrolyte monitoring protocols often remain consistent across generics)

Forecast sensitivity drivers (what moves revenue)

Even without a numeric forecast, decision-grade drivers can be listed as the revenue model levers:

• Utilization trend in hypertension (new prescriptions vs continuation)
• Switching away from older thiazides in some payer ecosystems that prefer newer agents (ACE/ARB/CCB, thiazide-like diuretics in certain guidelines)
• Safety monitoring behavior (electrolyte testing frequency changes adherence and clinician confidence)
• Generic supply and pricing dynamics (tender outcomes, wholesaler distribution)

These factors determine whether volumes are stable, declining, or volatile even when clinical differentiation is minimal.

What is a defensible projection approach if you need forward-looking numbers?

A numeric forecast requires input market series and product-level assumptions that are not included in the request. Without that, only a framework can be stated.

Projection framework (revenue = units × net price)

1. Estimate treated patient count in the hypertension segment where this FDC is used.
2. Apply penetration (share of those patients on the specific FDC rather than monotherapy or other combinations).
3. Apply persistence/continuation (average duration on therapy).
4. Convert to units using dosing regimen (commonly once- or twice-daily depending on local product strength and label).
5. Apply net price:
   • Adjust for discounts and payer mix.
   • Model periodic price resets typical for generic portfolios.
6. Add scenario bands based on:
   • Formulary access changes
   • Generic entry/exit
   • Tender pricing
   • Safety-event-driven switching

What “success” looks like for an FDC in this class

In this therapeutic area, the commercial goal is less “new efficacy” and more:

• Maintain formulary access
• Prevent share erosion to alternative low-cost regimens
• Manage pricing pressure from competing generics

Where are the highest value research and IP levers for the combination?

For this specific FDC, the main differentiators in mature markets usually fall into:

• Line extensions (different strengths, packaging, or dosing regimens)
• Stability/formulation improvements (bioequivalence and manufacturability)
• Comparator studies that reinforce tolerability in real-world electrolyte outcomes
• Clinical evidence generation that supports payer coverage and guideline-consistent use

But no evidence sources are included in the request to map actual filings to outcomes.

Competitive landscape: what usually determines share in this niche?

Without product-specific data for competing SKUs, a decision-grade view focuses on competition mechanics:

Share drivers

• National formulary status and tier placement
• Tender outcomes (public sector procurement can dominate volume)
• BBW and monitoring requirements that influence prescribing behavior
• Patient adherence to a single-tablet regimen versus multiple-drug titration

Product attrition risk

• Generic price compression
• Manufacturing discontinuations
• Label or safety communication shifts that lead clinicians to choose alternatives

Key Takeaways

• Amiloride HCl + hydrochlorothiazide is an established thiazide plus potassium-sparing diuretic FDC used for hypertension and diuretic-related electrolyte management.
• A complete clinical-trials update cannot be produced from the information provided in this request.
• A numeric market analysis and forecast cannot be produced from the information provided in this request.
• The decision model for revenue projection in this category is units × net price, driven by formulary access, generic pricing, and persistence rather than new clinical differentiation.

FAQs

1. What is the therapeutic purpose of combining amiloride with hydrochlorothiazide?
   To preserve potassium while delivering thiazide diuretic effects used in hypertension and related indications.

2. Is this combination typically protected by active patents?
   In most markets, the underlying drugs are widely available as generics; active exclusivity would usually be limited to specific product-level or formulation rights, which are not provided here.

3. What endpoints matter most for studies in this combination class?
   In routine clinical development, electrolyte outcomes (potassium-related measures) and blood pressure control typically matter most.

4. What commercial factor most strongly affects revenue for mature diuretic FDCs?
   Generic pricing and formulary/tender placement.

5. What is the simplest forecast model for an off-patent FDC like this?
   Revenue as treated patients × penetration × persistence × net price, with net price shaped by generic competition.

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References

[1] No external clinical-trials or market sources were provided in the prompt.