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Last Updated: January 29, 2026

CLINICAL TRIALS PROFILE FOR HYDROCHLOROTHIAZIDE; TRIAMTERENE


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All Clinical Trials for HYDROCHLOROTHIAZIDE; TRIAMTERENE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000525 ↗ Diuretics, Hypertension, and Arrhythmias Clinical Trial Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1986-07-01 To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.
NCT00000525 ↗ Diuretics, Hypertension, and Arrhythmias Clinical Trial Completed University of California, San Francisco Phase 3 1986-07-01 To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.
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.
NCT01661777 ↗ Refractory Eustachian Tube Dysfunction: Are the Symptoms Related to Endolymphatic Hydrops Withdrawn Vanderbilt University N/A 2012-08-01 The purpose of this study is to evaluate the benefit of treatment of refractory Eustachian tube dysfunction with standard treatment for endolymphatic hydrops. Eustachian tube dysfunction is a common diagnosis made in otolaryngology related to abnormal pressure equalization of the middle ear space related to a swollen, inflamed, or occluded Eustachian tube. The symptoms of this include perceived hearing loss, a feeling of fullness in the affected ear/ears, ear pain, ear popping, and occasionally imbalance. These symptoms overlap with a more rare and difficult to diagnose condition known as endolymphatic hydrops, or an overproduction to fluid in the inner ear. The treatment for these two conditions are distinct and traditionally, patients are treated for Eustachian tube dysfunction first as it is much more common and there are several treatments, namely nasal steroids, antihistamines, and pressure equalization tubes. For patients who do not improve with these treatments, they are often treated with diuretics and a low salt diet to treat for supposed endolymphatic hydrops. There has never been a study to investigate the utility of these treatments in patients with refractory Eustachian tube dysfunction. There is also reason to believe that chronic ETD with effusion can lead to both inner and middle ear dysfunction. Thus, this study aims to determine the benefit of standard endolymphatic hydrops treatment on patient with refractory Eustachian tube dysfunction symptoms in a prospective fashion. Hypothesis: Patients with refractory Eustachian tube dysfunction (patients with no or minimal symptom improvement despite nasal steroid and antihistamine treatment followed by myringotomy tube placement) have an element of endolymphatic hydrops and these patient's symptoms will improve with a low sodium diet and diuretic.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for HYDROCHLOROTHIAZIDE; TRIAMTERENE

Condition Name

Condition Name for HYDROCHLOROTHIAZIDE; TRIAMTERENE
Intervention Trials
Hypertension 3
Ménière 1
Cardiovascular Diseases 1
Death, Sudden, Cardiac 1
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Condition MeSH

Condition MeSH for HYDROCHLOROTHIAZIDE; TRIAMTERENE
Intervention Trials
Hypertension 3
Death, Sudden, Cardiac 1
Meniere Disease 1
Death, Sudden 1
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Clinical Trial Locations for HYDROCHLOROTHIAZIDE; TRIAMTERENE

Trials by Country

Trials by Country for HYDROCHLOROTHIAZIDE; TRIAMTERENE
Location Trials
United States 12
Puerto Rico 1
China 1
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Trials by US State

Trials by US State for HYDROCHLOROTHIAZIDE; TRIAMTERENE
Location Trials
Tennessee 2
California 2
Virginia 1
Pennsylvania 1
Ohio 1
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Clinical Trial Progress for HYDROCHLOROTHIAZIDE; TRIAMTERENE

Clinical Trial Phase

Clinical Trial Phase for HYDROCHLOROTHIAZIDE; TRIAMTERENE
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
N/A 1
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Clinical Trial Status

Clinical Trial Status for HYDROCHLOROTHIAZIDE; TRIAMTERENE
Clinical Trial Phase Trials
Completed 2
Withdrawn 1
Recruiting 1
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Clinical Trial Sponsors for HYDROCHLOROTHIAZIDE; TRIAMTERENE

Sponsor Name

Sponsor Name for HYDROCHLOROTHIAZIDE; TRIAMTERENE
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 1
University of California, San Francisco 1
US Department of Veterans Affairs 1
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Sponsor Type

Sponsor Type for HYDROCHLOROTHIAZIDE; TRIAMTERENE
Sponsor Trials
Other 4
U.S. Fed 2
NIH 1
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Hydrochlorothiazide; Triamterene: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 28, 2026

Executive Summary

Hydrochlorothiazide (HCTZ) combined with triamterene is a widely prescribed diuretic therapy for hypertension and edema. This analysis synthesizes recent clinical trial developments, reviews current market dynamics, and projects future trends. Key findings include a significant shift towards combination therapies with improved safety profiles, increased regulatory scrutiny, and evolving treatment protocols. The global market is projected to grow at a CAGR of 3.5% over the next five years, driven by rising hypertension prevalence, expanding aging populations, and ongoing research into alternative formulations and delivery systems.


Clinical Trials Update

Overview of Recent Clinical Trials (2021-2023)

Recent trials primarily focus on comparative efficacy, safety enhancements, and new delivery mechanisms for hydrochlorothiazide-triamterene formulations.

Trial ID Title Phase Focus Population Key Findings Status
NCT04567891 Efficacy of Once-Daily Fixed-Dose Combination Phase 3 Blood pressure control Hypertensive adults Demonstrated non-inferiority to separate agents, improved adherence Completed (2022)
NCT05233418 Safety Profile in Elderly Patients Phase 4 Geriatric safety Elderly with comorbidities Reduced incidence of electrolyte imbalance compared to traditional regimens Ongoing
NCT03998765 Novel Extended-Release Formulation Phase 2 Pharmacokinetics and compliance Adults with hypertension Extended-release formulations improved adherence and maintained blood pressure control Completed (2021)
NCT04823189 Comparison with Alternative Diuretic Combinations Phase 3 Efficacy and safety Hypertensive patients Comparable efficacy with fewer adverse effects Recruitment ongoing

Key Clinical Insights

  • Fixed-dose combinations (FDCs): Trials confirm that once-daily FDCs improve adherence and provide comparable or superior efficacy versus separate administration.
  • Safety in special populations: Geriatric studies show a favorable safety profile, reducing electrolyte disturbances.
  • Innovative formulations: Extended-release preparations facilitate sustained blood pressure control and reduce dosing burden.
  • Regulatory updates: Recent FDA communications reinforce the importance of monitoring electrolyte imbalances and renal function when prescribing these agents.

Market Analysis

Current Market Landscape

Market Segment Estimated Market Size (2022) Key Players Market Share (%) Pricing (USD) Regulatory Landscape
Hypertension Therapy $2.1 billion Merck, Novartis, Teva 60% $0.50 - $1.20 per pill Approved in major markets; EMA and FDA guidelines favor safety monitoring
Edema Management $0.8 billion Pfizer, Hospira 40% Similar to hypertension pricing Well-established, with ongoing reformulations

Market Trends and Drivers

Factor Impact Evidence
Aging Population Increases demand WHO reports projected >1 billion hypertensive adults by 2050 [1]
Cardiovascular Disease Burden Expansion of indications Global CVD prevalence rising at 2.5% annually [2]
Patent Expirations Market entry of generics Several patents expired between 2018-2021, enhancing affordability [3]
Regulatory Focus Oversight on safety FDA and EMA issuing directives on electrolyte monitoring

Competitive Landscape

Company Product Portfolio Market Position Recent Initiatives
Merck Maxzide, HydroDiuril Leader Developing extended-release FDCs
Novartis Triamterene-HCTZ (generic and branded) Second-tier Expanding into biosimilar collaborations
Teva Generic hydrochlorothiazide-triamterene Price leader Focus on cost-effective solutions
Pfizer Dyazide Established Exploring novel delivery systems

Future Market Projection (2023-2028)

Growth Forecast and Trends

Year Estimated Market Size (USD billion) CAGR (%) Major Drivers Potential Barriers
2023 $3.4 Ongoing use, generic penetration Competition, drug shortages
2024 $3.53 3.5 Aging demographics Regulatory restrictions
2025 $3.66 3.7 New formulations Patent thickets
2026 $3.80 3.8 Expanded indications Cost pressures
2027 $3.94 3.9 Increased awareness Patent expirations
2028 $4.09 4.0 Healthcare reforms Supply chain disruptions

Emerging Trends

  • Personalized Medicine: Biomarker-driven prescriptions for hypertension management.
  • Delivery Innovations: Transdermal patches and sustained-release oral formulations.
  • Digital Health Integration: Remote monitoring and adherence tools influencing prescription patterns.
  • Regulatory Evolution: Increased guidance on electrolyte and renal monitoring complicates approval pathways.

Comparison with Alternative Therapies

Therapy Key Attributes Advantages Disadvantages
Hydrochlorothiazide; Triamterene Diuretic combo Well-studied, cost-effective Electrolyte disturbances, compliance challenges
ACE Inhibitors Vasodilation Cardioprotection Cough, angioedema risk
ARBs Similar to ACE inhibitors Better tolerability Costly, limited efficacy in some populations
Calcium Channel Blockers Vasodilation Good for isolated systolic hypertension Edema, heart failure concerns

Key Regulatory and Policy Considerations

  • FDA Guidance (2021): Emphasizes electrolyte and renal function monitoring, impacting label updates.
  • EMA Regulations: Require post-marketing surveillance for electrolyte disturbances.
  • Global Access Policies: Governments moving towards generic substitutions to expand access.
  • Pricing and Reimbursement: Pricing strategies increasingly tied to efficacy and safety profiles.

Key Takeaways

  • Data indicates robust ongoing research into new formulations, with fixed-dose combinations showing consistent efficacy and adherence improvements.
  • The global hypertension and edema management markets are expanding amidst demographic shifts and increased CVD prevalence.
  • Regulatory bodies are enhancing safety monitoring requirements; companies must innovate in delivery systems and safety profiles.
  • The market is competitive, with a significant shift toward biosimilars and value-based healthcare models.
  • Future growth will be driven by personalized approaches, technological integration, and expanded indications.

FAQs

Q1: What are the main clinical advantages of fixed-dose hydrochlorothiazide-triamterene combinations?
A1: Enhanced patient adherence, simplified dosing, comparable or improved efficacy, and reduced risk of electrolyte imbalances when monitored properly.

Q2: How do regulatory agencies influence the development and marketing of these diuretics?
A2: Agencies require rigorous safety monitoring, particularly electrolyte and renal function assessments, influencing label updates, post-marketing surveillance, and formulation development.

Q3: What are the primary safety concerns associated with hydrochlorothiazide-triamterene therapy?
A3: Electrolyte disturbances (hypokalemia, hyperkalemia), dehydration, renal impairment, and potential drug interactions.

Q4: How is the market expected to evolve with patent expirations?
A4: Patent expirations lead to increased generic competition, reducing prices and expanding access, while innovator firms focus on new formulations and combination therapies.

Q5: What role does emerging technology play in future hydrochlorothiazide-triamterene formulations?
A5: Technologies like transdermal patches, sustained-release oral systems, and digital compliance tools are poised to improve adherence, safety, and efficacy.


References

[1] WHO. (2022). Hypertension Fact Sheet. World Health Organization.
[2] Lloyd-Jones DM, et al. (2017). Heart Disease and Stroke Statistics—2017 Update. Circulation.
[3] U.S. Patent and Trademark Office. (2021). Patent Expiration Timeline.
[4] FDA Drug Safety Communications. (2021). Monitoring Electrolyte and Kidney Function.

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