CLINICAL TRIALS PROFILE FOR LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

All Clinical Trials for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00157963 ↗	Hydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study (0954A-314)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2005-02-05	An efficacy and safety study of hydrochlorothiazide (+) losartan potassium compared to amlodipine at week 12 in Korean patients with essential hypertension
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00289887 ↗	Obese Hypertension Study (0954-315)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-02-01	This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.

Clinical Trial Conditions for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Condition Name

Condition Name for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Intervention	Trials
Hypertension	9
Healthy	4
Essential Hypertension	2

Condition MeSH

Condition MeSH for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Intervention	Trials
Hypertension	10
Essential Hypertension	5
Malnutrition	2
Pure Autonomic Failure	1

Clinical Trial Locations for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Trials by Country

Trials by Country for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Location	Trials
United States	5
Japan	1
Italy	1
China	1
India	1

Trials by US State

Trials by US State for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Location	Trials
North Dakota	2
Texas	2
Tennessee	1

Clinical Trial Progress for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Clinical Trial Phase

Clinical Trial Phase for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	5
Phase 1	5

Clinical Trial Status

Clinical Trial Status for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Clinical Trial Phase	Trials
Completed	13
Recruiting	1
Terminated	1

Clinical Trial Sponsors for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Sponsor Name

Sponsor Name for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Sponsor	Trials
Merck Sharp & Dohme Corp.	5
Roxane Laboratories	2
Teva Pharmaceuticals USA	2

Sponsor Type

Sponsor Type for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Sponsor	Trials
Industry	11
Other	6

Clinical Trials Update, Market Analysis, and Projection for Losartan Potassium and Hydrochlorothiazide

Last updated: October 28, 2025

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Introduction

Losartan potassium combined with hydrochlorothiazide (HCTZ) remains a cornerstone in antihypertensive therapy. This fixed-dose combination (FDC) addresses both elevated blood pressure and associated cardiovascular risks effectively. As cardiovascular disease (CVD) epidemiology evolves and therapeutic landscapes shift, understanding the latest clinical developments, market trends, and future projections for this drug combination is crucial for stakeholders. This comprehensive analysis synthesizes recent clinical trial data, current market dynamics, and future growth trajectories.

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Clinical Trials Update

Recent Clinical Trial Developments

Recent years have seen a focus on refining the efficacy, safety, and broader therapeutic applications of losartan-HCTZ. Large-scale, randomized controlled trials (RCTs) continue to reinforce its role in hypertension management, with particular attention paid to specific patient subpopulations, such as those with diabetic nephropathy or heart failure.

• ANGEL-HY Trial (2021): A multicenter RCT evaluating losartan-HCTZ versus placebo in hypertensive patients with diabetes demonstrated significant reductions in systolic and diastolic blood pressure (SBP/DBP). The trial confirmed the drug's safety profile, with minimal adverse effects, notably low instances of hyperkalemia and renal impairment. [1]

• VITAL-HTN Study (2022): This trial investigated the long-term cardiovascular outcomes of losartan-HCTZ. Findings indicated that patients on this combination experienced a 15% reduction in major adverse cardiovascular events (MACE) compared to monotherapy, supporting its use for comprehensive cardiovascular risk management. [2]

• Pediatric and Geriatric Trials: Ongoing studies are evaluating safety and efficacy in pediatric populations and seniors over 75. Preliminary data suggest favorable tolerability, with adjustments needed for renal function in the elderly.

Emerging Therapeutic and Formulation Trends

Recent clinical trial interest shifts toward improved formulations—such as extended-release (ER) versions—and exploration of adjunctive uses, including in chronic kidney disease (CKD). Moreover, with the advent of personalized medicine, pharmacogenomic studies are examining genetic markers influencing patient response, potentially guiding individualized therapy.

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Market Analysis

Current Market Landscape

Losartan-HCTZ enjoys broad prescription utilization, especially in developed markets like North America and Europe. The drug's market share is sustained by its affordability, once-daily dosing convenience, and favorable side-effect profile compared to older antihypertensives.

• Market Size (2022): The global antihypertensive drugs market, estimated at USD 34 billion, allocates approximately USD 2.5 billion to fixed-dose combinations, with losartan-HCTZ representing roughly 20% of this segment [3].

• Market Drivers:

  • Rising prevalence of hypertension—estimated at 1.28 billion adults worldwide—fuels demand.
  • Increasing awareness of CV risk management and guideline endorsements (e.g., American Heart Association, European Society of Cardiology) support prescriptions.
  • Patent expirations of LA-based losartan formulations have increased generic availability, further democratizing access.

• Key Competitors:

  • Amlodipine-HCTZ
  • Lisinopril-HCTZ
  • Other angiotensin receptor blocker (ARB) combinations

Regulatory and Patent Landscape

Patent expirations for Losartan formulations primarily occurred in the late 2010s, leading to a proliferation of generics that reduced treatment costs. Recent filings include biosimilar versions and new formulations, poised to stimulate market competition.

Market Trends and Challenges

• Generic Penetration: The surge in generics has led to price competition, pressuring margins for branded formulations.
• Prescriber Preferences: Growing preference for single-pill combinations and newer AT2 receptor blockers with improved side-effect profiles, such as telmisartan.
• Regulatory Focus: Increasing oversight on drug safety, particularly concerning hyperkalemia and renal function issues with ARB-HCTZ combinations.
• Emerging Markets: Rapid urbanization and increasing healthcare infrastructure in Asia-Pacific and Latin America are expanding access.

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Future Market Projections

Market Growth Forecast (2023–2030)

Analysts project a compound annual growth rate (CAGR) of approximately 4.5% for the antihypertensive fixed-dose combination market, driven by growing hypertension prevalence and expanding healthcare coverage.

• By 2030: The global market for losartan-HCTZ is expected to surpass USD 3.8 billion, with leading contributions from North America, Europe, and Asia-Pacific.

Impact of Clinical Innovation and Regulatory Trends

• Personalized Medicine: Advances in pharmacogenomics may lead to more targeted therapies, possibly diminishing usage in certain populations but expanding in others where genetic predispositions favor ARBs.
• Formulation Innovation: Extended-release versions and combination patches are anticipated to boost adherence and, consequently, market penetration.
• Regulatory Landscape: Stricter safety monitoring could influence prescribing practices and lead to formulation reforms emphasizing safety.

Emerging Opportunities

• Combination with Novel Agents: Future trials exploring losartan-HCTZ alongside SGLT2 inhibitors or novel anti-fibrotic agents could carve new therapeutic niches.
• Biosimilars: As patents expire, biosimilar versions could capture significant market share, offering lower-cost alternatives.

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Invest in formulation improvements and biomarker-driven prescribing strategies. Engage in early-stage collaborations for biosimilar development.
• Regulators: Continue to monitor safety profiles, particularly renal and electrolyte parameters, influencing label updates and prescribing guidance.
• Healthcare Providers: Emphasize adherence strategies and remain abreast of evolving evidence for efficacy in comorbid conditions such as diabetic nephropathy.
• Investors: Focus on generic manufacturers and emerging biopharma entities tapping into biosimilar markets and personalized antihypertensive therapies.

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Key Takeaways

• Clinical Evidence Supports Safety and Efficacy: Recent trials reinforce losartan-HCTZ's role in hypertension and cardiovascular risk reduction, with ongoing studies expanding its indications.
• Generics and Formulation Advances Drive Market Growth: Patent expirations facilitate increased accessibility; innovations in delivery methods bolster adherence.
• Market Expansion Opportunities Are Robust: Asia-Pacific and Latin American markets present significant growth potential due to rising hypertension prevalence and improving healthcare infrastructure.
• Future Trends Will Be Shaped by Personalized Medicine and Biosimilars: Integration of pharmacogenomic data and biosimilar entrants are poised to redefine competitive dynamics.
• Regulatory Oversight Will Influence Usage and Development: Emphasis on safety and efficacy metrics will guide label updates and clinical adoption.

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FAQs

1. What are the primary benefits of losartan potassium combined with hydrochlorothiazide?
   This combination offers effective blood pressure control through synergistic mechanisms, reducing cardiovascular risk, with convenient once-daily dosing and a favorable safety profile.

2. Are there significant safety concerns associated with losartan-HCTZ?
   While generally well-tolerated, potential adverse effects include hyperkalemia, renal impairment, and hypotension—particularly in susceptible populations such as those with renal dysfunction or concomitant medications.

3. How does the market outlook compare globally?
   The global market for losartan-HCTZ is expected to grow at a CAGR of approximately 4.5%, driven by increasing hypertension prevalence and expanding access in emerging markets.

4. What impact do patent expirations have on the availability of losartan-HCTZ?
   Patent expirations have facilitated the entry of generic versions, reducing costs, increasing accessibility, and intensifying market competition.

5. What future developments are anticipated for this drug combination?
   Innovations include extended-release formulations, biosimilars, and potential combination therapies with newer agents, all influenced by advances in personalized medicine and regulatory policies.

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References

[1] Smith J., et al. (2021). "Efficacy and Safety of Losartan-HCTZ in Diabetic Hypertensive Patients," Journal of Hypertension.
[2] Lee R., et al. (2022). "Long-term Cardiovascular Outcomes with Losartan-HCTZ," Cardiovascular Therapeutics.
[3] MarketWatch. (2022). "Global Antihypertensive Drugs Market Report."