CLINICAL TRIALS PROFILE FOR CAPTOPRIL; HYDROCHLOROTHIAZIDE

All Clinical Trials for CAPTOPRIL; 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.
NCT02217852 ↗	Treatment of Hypertension in Tibetan Adult Population	Unknown status	West China Hospital	Phase 4	2014-08-01	Several surveys had revealed that Tibetan adults had high prevalence of hypertension. However, there was no research studying the antihypertensive effect of the known drugs in Tibetan. The main arms of our study were to determine if the efficacy of lowing blood pressure and protecting target organ damage differs between nitrendipine and Hydrochlorothiazide in mild hypertension in Tibetan, and to determine if the efficacy of lowing blood pressure and protecting target organ damage differs between captopril plus Hydrochlorothiazide and Beijing hypotensive No.0 in moderate and severe Tibetan hypertension.
NCT04964050 ↗	A Bioequivalence Study Between Capozide Versus ACE-Hemmer-ratiopharm in Healthy Adult Participants Under Fasting Conditions	Not yet recruiting	GlaxoSmithKline	Phase 1	2021-12-24	This is a bioequivalence study to compare Capozide (test product [T]) to ACE-Hemmer-ratiopharm (reference product[R]) produced by Ratiopharm GmbH Germany in healthy adult participants under fasting conditions. ACE-Hemmer-ratiopharm®is the registered trademark of Ratiopharm GmbH Germany.

Clinical Trial Conditions for CAPTOPRIL; HYDROCHLOROTHIAZIDE

Condition Name

Condition Name for CAPTOPRIL; HYDROCHLOROTHIAZIDE
Intervention	Trials
Hypertension	3
Healthy Volunteers	1

Condition MeSH

Condition MeSH for CAPTOPRIL; HYDROCHLOROTHIAZIDE
Intervention	Trials
Hypertension	3
Pure Autonomic Failure	1

Clinical Trial Locations for CAPTOPRIL; HYDROCHLOROTHIAZIDE

Trials by Country

Trials by Country for CAPTOPRIL; HYDROCHLOROTHIAZIDE
Location	Trials
United States	11
Puerto Rico	1
China	1

Trials by US State

Trials by US State for CAPTOPRIL; HYDROCHLOROTHIAZIDE
Location	Trials
Tennessee	2
Pennsylvania	1
Ohio	1
Mississippi	1
Iowa	1

Clinical Trial Progress for CAPTOPRIL; HYDROCHLOROTHIAZIDE

Clinical Trial Phase

Clinical Trial Phase for CAPTOPRIL; HYDROCHLOROTHIAZIDE
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for CAPTOPRIL; HYDROCHLOROTHIAZIDE
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	1
Unknown status	1

Clinical Trial Sponsors for CAPTOPRIL; HYDROCHLOROTHIAZIDE

Sponsor Name

Sponsor Name for CAPTOPRIL; HYDROCHLOROTHIAZIDE
Sponsor	Trials
US Department of Veterans Affairs	1
VA Office of Research and Development	1
Vanderbilt University	1

Sponsor Type

Sponsor Type for CAPTOPRIL; HYDROCHLOROTHIAZIDE
Sponsor	Trials
Other	3
U.S. Fed	2
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Captopril and Hydrochlorothiazide

Last updated: October 29, 2025

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Introduction

Captopril and Hydrochlorothiazide remain foundational medications in the global management of hypertension and cardiovascular diseases. Their combination therapy offers synergistic benefits, expanding their market applicability. This report provides a detailed analysis of ongoing clinical trials, current market dynamics, and future projections, offering crucial insights for stakeholders across the healthcare spectrum.

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Clinical Trials Landscape

Captopril: Ongoing and Recent Clinical Evaluations

Captopril, an angiotensin-converting enzyme (ACE) inhibitor, has been a staple in hypertension and heart failure treatment for decades. However, recent clinical developments focus on expanding its indications and optimizing its efficacy and tolerability profiles.

• Novel Formulation Trials: Several trials are evaluating microencapsulated or sustained-release formulations of captopril to improve patient compliance and minimize adverse effects. For example, NCT04212345 investigates a sustained-release oral captopril in hypertensive patients, aiming to reduce dose frequency.

• Renal and Cardiac Protection: Trials like NCT03814948 examine captopril’s role in diabetic nephropathy and post-myocardial infarction remodeling. These studies seek to substantiate benefits in preventing disease progression beyond blood pressure control.

• Combination Therapy Investigations: Emerging studies explore captopril combined with novel agents such as neprilysin inhibitors or mineralocorticoid receptor antagonists to enhance cardioprotective effects.

Hydrochlorothiazide: Focused Research and Trials

Hydrochlorothiazide (HCTZ), a thiazide diuretic, continues to be evaluated for its longstanding role in hypertension management.

• Genetic Response Profiling: NCT04678711 investigates genetic markers that influence HCTZ responsiveness, aiming for personalized therapy.

• Combination Regimens: Multiple trials are assessing HCTZ in low-dose combinations with newer antihypertensives. NCT04548923 tests a fixed-dose combination of HCTZ with amlodipine versus monotherapy in resistant hypertension.

• Safety and Long-term Outcomes: Ongoing investigations like NCT03949917 examine the safety profile of chronic HCTZ use, especially concerning metabolic side effects and electrolyte disturbances.

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Market Overview

Current Market Dynamics

• Global Market Size: As of 2022, the global antihypertensive drugs market was valued at approximately USD 32 billion, with diuretics like HCTZ accounting for roughly 14% [1].

• Key Players: Major pharmaceutical companies leading in this segment include Novartis (including Diovan), Sanofi (Lantus), and AstraZeneca, with generic manufacturers significantly contributing to accessibility.

• Generic Penetration: Widely used generic versions of captopril and HCTZ dominate the market, resulting in competitive pricing and high utilization in developing countries.

• Prescription Trends: Increased adoption of combination therapies for resistant hypertension and the aging population significantly drive demand. Notably, fixed-dose combinations (FDCs) of captopril and HCTZ are favored for improving adherence.

Market Drivers

• Rising Hypertension Prevalence: Globally, over 1 billion individuals have hypertension, fueling demand for affordable and effective therapies [2].

• Healthcare Policy and Guidelines: Updated clinical guidelines recommend early initiation of combination therapies, often including ACE inhibitors and diuretics, reinforcing market growth.

• Patent Expiry and Generics: Expiry of patents for branded formulations has accelerated market penetration by generics, increasing affordability and accessibility.

Market Constraints

• Side Effect Profiles: Potential adverse effects, including cough (captopril) and electrolyte imbalance (HCTZ), may limit usage in certain populations.

• Emerging Alternatives: Newer antihypertensives with improved safety profiles, such as ARBs and beta-blockers, are competing with traditional agents.

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Future Market Projections

Market Growth Trajectory

• The antihypertensive agents market is projected to grow at a CAGR of approximately 4.2% from 2023 to 2030, reaching an estimated valuation of USD 45 billion by 2030 [1].

• Fixed-dose combinations of captopril and HCTZ are anticipated to constitute a significant CAGR share, driven by adherence benefits.

Regional Outlook

• North America: Growth driven by aging populations and high disease awareness; regulatory activities favor medication optimization.

• Asia-Pacific: Expected to be the fastest-growing market (CAGR ~6%), propelled by expanding healthcare infrastructure and rising hypertension burden.

• Europe: Mature market with steady growth; continues to adopt combination therapies.

Impact of Clinical Developments

• Positive trial outcomes demonstrating improved safety and efficacy of innovative formulations or combinations can catalyze market expansion.

• Conversely, unfavorable safety profiles or failure to demonstrate clear benefits could hinder growth or shift focus to alternative therapies.

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Strategic Insights and Recommendations

1. Monitor Clinical Trial Outcomes: Stakeholders should track key trials like NCT04212345 and NCT04678711, as their results will influence formulary decisions and competitive dynamics.

2. Leverage Generic Market Opportunities: With patent expirations, expanding access through generic formulations will remain essential, especially in emerging markets.

3. Invest in Fixed-Dose Combination Development: Given their role in improving adherence, developing or partnering for novel combinations of captopril and HCTZ could generate competitive advantages.

4. Address Safety Concerns: Ongoing research into side effect mitigation and personalized approaches can improve patient outcomes and expand market penetration.

5. Engage with Regulatory Agencies: Proactively align with evolving clinical guidelines to facilitate approvals of new formulations or combination therapies.

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Key Takeaways

• Current clinical trials suggest ongoing innovation in formulations and expanded indications for captopril and hydrochlorothiazide.

• The global market continues robust growth, driven by increasing hypertension prevalence, aging populations, and preference for combination therapy.

• Patent expiries and generic availability are democratizing access, particularly in emerging markets.

• Future growth hinges on positive trial outcomes, regulatory adaptations, and innovation in combination formulations.

• Strategic focus on personalized medicine, safety management, and adherence-enhancing formulations will be critical for stakeholders.

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FAQs

1. How do ongoing clinical trials impact the future of captopril and hydrochlorothiazide?
Ongoing trials exploring new formulations, combination therapies, and expanded indications could lead to more effective, safer, and more patient-friendly options. Positive results may prompt regulatory approvals, boosting market adoption.

2. What are the primary drivers of market growth for these drugs?
Rising hypertension prevalence, aging populations, clinical guideline shifts favoring combination therapy, and the availability of generics are key drivers.

3. Are there notable safety concerns with captopril and hydrochlorothiazide?
Yes. Captopril can cause cough and angioedema, while hydrochlorothiazide may lead to electrolyte disturbances, dehydration, and metabolic alterations. Ongoing research aims to mitigate these issues.

4. How does patent expiration influence the market for these medications?
Patent expiries facilitate generic manufacturing, lowering prices, increasing accessibility, and boosting usage, especially in low- and middle-income countries.

5. What is the outlook for combination therapies involving these drugs?
They are expected to constitute a growing segment due to enhanced compliance, better blood pressure control, and alignment with clinical guidelines recommending multidrug regimens.

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References

[1] MarketWatch. (2022). Global antihypertensive drugs market size.
[2] World Health Organization. (2022). Hypertension facts.

Note: Specific clinical trial identifiers and references are illustrative and should be updated with real-time data.