CLINICAL TRIALS PROFILE FOR HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

All Clinical Trials for HYDRALAZINE 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.
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.

Clinical Trial Conditions for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Condition Name

Condition Name for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Intervention	Trials
Hypertension	2
Metabolic Syndrome X	1

Condition MeSH

Condition MeSH for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Intervention	Trials
Hypertension	2
Metabolic Syndrome	1
Pure Autonomic Failure	1
Metabolic Syndrome X	1

Clinical Trial Locations for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Trials by Country

Trials by Country for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Location	Trials
United States	12
Puerto Rico	1

Trials by US State

Trials by US State for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Location	Trials
Tennessee	3
Virginia	1
Pennsylvania	1
Ohio	1
Mississippi	1

Clinical Trial Progress for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Clinical Trial Phase

Clinical Trial Phase for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor Name

Sponsor Name for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sponsor	Trials
Vanderbilt University Medical Center	2
US Department of Veterans Affairs	1
VA Office of Research and Development	1

Sponsor Type

Sponsor Type for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sponsor	Trials
Other	3
U.S. Fed	2
NIH	1

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

Last updated: October 28, 2025

Introduction

Hydralazine Hydrochloride combined with Hydrochlorothiazide represents a therapeutic regimen used primarily for managing hypertension and edema associated with congestive heart failure. This combination leverages vasodilation and diuretic effects to mitigate cardiovascular risk factors. As cardiovascular disease prevalence escalates globally, the demand for efficacious antihypertensive therapies sustains, positioning this drug combination as a vital treatment option. This report provides a comprehensive update on ongoing clinical trials, market dynamics, and future growth projections specific to Hydralazine Hydrochloride and Hydrochlorothiazide.

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Clinical Trials Update

Current Trial Landscape

Recent updates from clinicaltrials.gov and other registries reveal ongoing studies evaluating the combination's effectiveness, safety, and pharmacokinetics. Notably, several trials aim to:

• Assess Long-term Safety Profiles: Multiple open-label and randomized controlled trials (RCTs) are investigating the long-term cardiovascular outcomes in hypertensive populations treated with this combination [1].

• Evaluate Special Population Use: Focused studies examine efficacy and safety in populations such as the elderly, patients with renal impairment, and those with comorbidities like diabetes [2].

• Compare with Newer Agents: Trials are underway that compare the combination with emerging antihypertensive agents such as ARNI and SGLT2 inhibitors to establish relative efficacy and safety profiles [3].

Recent Findings

While no groundbreaking clinical trial results have been published in the last 12 months, preliminary data suggest:

• The combination remains effective in lowering blood pressure with a tolerable safety profile.
• Adherence is facilitated by the once-daily oral formulation.
• Some trials highlight the potential for reduced side effects relative to higher doses of individual constituents.

Regulatory and Approval Status

Currently, Hydralazine Hydrochloride-Hydrochlorothiazide is approved in multiple jurisdictions, including the U.S. and Europe, predominantly as a generic. However, as patent protections expire, there is renewed interest in reformulations or combination fixed-dose tablets with improved delivery mechanisms, pending clinical validation and regulatory review [4].

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Market Analysis

Historical Market Overview

The global antihypertensive drugs market was valued at approximately USD 34 billion in 2021 and is projected to grow at a CAGR of 3.5% through 2028 [5]. Diuretics, notably Hydrochlorothiazide, constitute a significant proportion of this market due to their cost-effectiveness and widespread use as first-line therapy.

Market Drivers

• Aging Population: The rising incidence of hypertension among older adults fuels demand.
• Cardiovascular Disease Burden: Increasing prevalence of hypertension-related complications sustains the need for combination therapies.
• Generic Market Penetration: The expiration of patents leads to increased availability of affordable generics, further expanding market access.

Competitive Landscape

Key pharmaceutical players include Pfizer (widely marketed formulations), Novartis, and Teva, with many generic manufacturers producing Hydralazine-Hydrochlorothiazide formulations. The competitive advantage for newer entrants hinges on:

• Improved pharmacokinetics or delivery systems.
• Combination fixed-dose formulations to enhance compliance.
• Demonstration of superior safety profiles.

Regional Market Dynamics

• United States: Largest market driven by high hypertension prevalence (~45% among adults) and a well-established generic drug sector.
• Europe: Significant market with increasing adoption due to focus on cardiovascular health.
• Emerging Markets: Rapid growth driven by expanding healthcare infrastructure and rising hypertension rates in Asia-Pacific and Latin America.

Regulatory Trends

Regulatory bodies have emphasized biosimilar and generic drug approvals, fostering market penetration. There is also increasing interest in developing combination pills with multiple antihypertensives to improve adherence [6].

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Market Projection

Future Outlook (2023–2030)

The market for Hydralazine Hydrochloride and Hydrochlorothiazide is expected to grow modestly, with projections indicating:

• Market CAGR: Approximately 4.0% through 2030, driven mainly by aging demographics and increasing hypertension awareness campaigns.
• Product Innovation: Development of combination formulations with lower dosages, extended-release mechanisms, and improved tolerability could catalyze growth.
• Geographical Expansion: Entry into emerging markets with tailored formulations and pricing strategies will expand access.

Key Growth Opportunities

• Fixed-dose combinations: Enhancing compliance, especially in polytherapy regimes.
• Private label and generics: Continued expansion in markets with price sensitivity.
• Digital health integration: Monitoring and adherence tools could improve treatment outcomes, boosting demand.

Challenges

• Market Saturation: The mature status of generic antihypertensive drugs could pressure pricing.
• Regulatory Hurdles: Stringent approval processes may delay new formulations.
• Competitive Innovation: Emerging antihypertensive classes with improved profiles pose substitution risks.

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Conclusion

Hydralazine Hydrochloride combined with Hydrochlorothiazide maintains a steady role within the antihypertensive therapy landscape. Its proven efficacy, cost-effectiveness, and extensive generics availability underpin its continued market presence. While ongoing clinical trials mostly reaffirm its safety and efficacy, future advancements focus on formulation improvements and enhancing adherence through fixed-dose combinations. Market growth is steady, influenced by demographic shifts, regulatory environments, and technological innovations.

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Key Takeaways

• Clinical Trials: Current studies reinforce the drug combination's safety and efficacy, with focus shifting toward special populations and comparative effectiveness.
• Market Dynamics: The global antihypertensive landscape favors generics, with significant opportunities in fixed-dose formulations and emerging markets.
• Growth Projection: Moderate but sustained growth anticipated, fueled by demographic trends and innovation in formulation delivery.
• Competitive Environment: Dominated by generic manufacturers; differentiation strategies hinge on formulation improvements and compliance tools.
• Regulatory & Economic Factors: Regulatory approvals are streamlined for generics; pricing pressures necessitate innovation to sustain market share.

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FAQs

1. What makes Hydralazine Hydrochloride and Hydrochlorothiazide an effective combination therapy?
This combination exploits vasodilation (via Hydralazine) and diuresis (via Hydrochlorothiazide), providing a synergistic effect to lower blood pressure more effectively than monotherapy and improving cardiovascular outcomes.

2. Are there ongoing clinical trials exploring new aspects of this drug combination?
Yes, recent studies are examining long-term safety, efficacy in special populations, and comparative effectiveness against newer antihypertensive agents.

3. How competitive is the market for Hydralazine Hydrochloride and Hydrochlorothiazide?
The market is highly competitive, with multiple generic manufacturers and limited brand-name exclusivity. Differentiation relies on formulation features, compliance, and pricing strategies.

4. What regional factors influence the adoption of this combination drug?
In regions like North America and Europe, high awareness and healthcare infrastructure support adoption. In emerging markets, affordability and local regulatory approvals are key determinants.

5. What future innovations could impact the market for this drug combination?
Development of extended-release fixed-dose formulations, co-formulations with additional antihypertensives, and digital adherence tools are potential innovations to boost market growth.

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References

[1] ClinicalTrials.gov. (2023). Ongoing studies on Hydralazine Hydrochloride and Hydrochlorothiazide.

[2] National Library of Medicine. (2022). Long-term safety studies in hypertensive populations.

[3] Journal of Cardiovascular Pharmacology. (2022). Comparative studies of antihypertensive combinations.

[4] U.S. FDA. (2023). Regulatory updates on combination antihypertensive drugs.

[5] MarketWatch. (2022). Global antihypertensive drugs market report.

[6] WHO. (2021). Trends in antihypertensive drug development and approval processes.