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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR HYDROCHLOROTHIAZIDE; LISINOPRIL


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All Clinical Trials for HYDROCHLOROTHIAZIDE; LISINOPRIL

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.
NCT00171535 ↗ Efficacy and Safety of Valsartan/Amlodipine Combination in Patients With Severe Hypertension Completed Novartis Phase 3 2004-10-01 This study will assess the effectiveness and safety of different combination antihypertensive treatments in patients with severe hypertension
NCT00408512 ↗ Pharmacosurveillance and Pharmacogenetics of First-line Diuretics in Hypertension: The StayOnDiur Study Completed Agenzia Italiana del Farmaco Phase 4 2006-12-01 Background: The use of thiazide diuretics in the treatment of hypertension (HT) is widely considered a first line treatment, given the efficacy and low cost of this class of drugs. This indication is not unanimous, because thiazides can cause metabolic alterations and other side effects increasing cardiac and cerebrovascular risk, which reduce compliance to treatment and increase health care system cost. However, large intervention trials in HT suggest that the improvement in cardiovascular prognosis of HT patients depends more on follow-up procedures than on type of drug used. Furthermore, the investigators have documented improved compliance to antihypertensive therapy by implementing cooperation between general practitioners (GPs) and HT specialists. Objectives: In a multicenter, open label randomized study the investigators will compare the persistence on therapy of thiazides versus other treatments, as a first line antihypertensive therapy, in a clinical setting characterized by a strict cooperation between GPs and HT specialist. The investigators will also analyse candidate genes with impact on drug-induced metabolic alterations to elucidate the pathophysiology of these phenomena. Methods: 260 GPs will recruit 2600 hypertensive patients with indication to pharmacological treatment and randomise them to starting treatment with chlortalidone (12.5 to 25 mg daily, 1300 pts) or a GP decided single drug (excluding thiazides) or combination therapy at highest tolerated dose. In both groups any other class of antihypertensive drugs can be added over time in order to achieve blood pressure control (
NCT00408512 ↗ Pharmacosurveillance and Pharmacogenetics of First-line Diuretics in Hypertension: The StayOnDiur Study Completed Federico II University Phase 4 2006-12-01 Background: The use of thiazide diuretics in the treatment of hypertension (HT) is widely considered a first line treatment, given the efficacy and low cost of this class of drugs. This indication is not unanimous, because thiazides can cause metabolic alterations and other side effects increasing cardiac and cerebrovascular risk, which reduce compliance to treatment and increase health care system cost. However, large intervention trials in HT suggest that the improvement in cardiovascular prognosis of HT patients depends more on follow-up procedures than on type of drug used. Furthermore, the investigators have documented improved compliance to antihypertensive therapy by implementing cooperation between general practitioners (GPs) and HT specialists. Objectives: In a multicenter, open label randomized study the investigators will compare the persistence on therapy of thiazides versus other treatments, as a first line antihypertensive therapy, in a clinical setting characterized by a strict cooperation between GPs and HT specialist. The investigators will also analyse candidate genes with impact on drug-induced metabolic alterations to elucidate the pathophysiology of these phenomena. Methods: 260 GPs will recruit 2600 hypertensive patients with indication to pharmacological treatment and randomise them to starting treatment with chlortalidone (12.5 to 25 mg daily, 1300 pts) or a GP decided single drug (excluding thiazides) or combination therapy at highest tolerated dose. In both groups any other class of antihypertensive drugs can be added over time in order to achieve blood pressure control (
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for HYDROCHLOROTHIAZIDE; LISINOPRIL

Condition Name

Condition Name for HYDROCHLOROTHIAZIDE; LISINOPRIL
Intervention Trials
Hypertension 8
Hypertension in Pregnancy 1
Hypertension Treatment 1
Hypertension, Grade 1 1
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Condition MeSH

Condition MeSH for HYDROCHLOROTHIAZIDE; LISINOPRIL
Intervention Trials
Hypertension 8
Pre-Eclampsia 1
Obesity, Abdominal 1
Hypertension, Pregnancy-Induced 1
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Clinical Trial Locations for HYDROCHLOROTHIAZIDE; LISINOPRIL

Trials by Country

Trials by Country for HYDROCHLOROTHIAZIDE; LISINOPRIL
Location Trials
United States 46
India 2
Puerto Rico 1
Italy 1
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Trials by US State

Trials by US State for HYDROCHLOROTHIAZIDE; LISINOPRIL
Location Trials
California 4
Massachusetts 2
New Jersey 2
Virginia 2
Pennsylvania 2
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Clinical Trial Progress for HYDROCHLOROTHIAZIDE; LISINOPRIL

Clinical Trial Phase

Clinical Trial Phase for HYDROCHLOROTHIAZIDE; LISINOPRIL
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for HYDROCHLOROTHIAZIDE; LISINOPRIL
Clinical Trial Phase Trials
Completed 10
Recruiting 1
Withdrawn 1
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Clinical Trial Sponsors for HYDROCHLOROTHIAZIDE; LISINOPRIL

Sponsor Name

Sponsor Name for HYDROCHLOROTHIAZIDE; LISINOPRIL
Sponsor Trials
IPCA Laboratories Ltd. 2
Hebrew SeniorLife 1
National Institute on Aging (NIA) 1
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Sponsor Type

Sponsor Type for HYDROCHLOROTHIAZIDE; LISINOPRIL
Sponsor Trials
Other 8
Industry 7
U.S. Fed 2
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Clinical Trials Update, Market Analysis, and Projection for Hydrochlorothiazide and Lisinopril

Last updated: January 27, 2026

Summary

Hydrochlorothiazide (HCTZ) and Lisinopril are longstanding medications used to manage hypertension and related cardiovascular conditions. Despite generic status, their market remains significant due to ongoing clinical updates, evolving treatment protocols, and aging populations globally. This report synthesizes recent clinical trial data, analyzes current market dynamics, and projects future trends for these drugs up to 2030.


Clinical Trials Update: Hydrochlorothiazide and Lisinopril

Hydrochlorothiazide (HCTZ): Recent Clinical Developments

Aspect Details
Latest Clinical Trials Some recent studies focus on safety concerns, particularly hypokalemia and hyponatremia risks (NCT04585210, 2022). Trials are also evaluating combination therapy efficacy with other antihypertensives (e.g., ACE inhibitors, ARBs).
FDA and EMA Positions No recent updates on HCTZ prescribing restrictions. However, ongoing safety concerns regarding its role in long-term cardiovascular outcomes are under review in post-marketing surveillance.
Emerging Research New meta-analyses (e.g., JAMA 2022) question the cardiovascular benefit-to-risk balance of low-dose HCTZ monotherapy, prompting clinicians to consider combination therapies or alternative diuretics.

Lisinopril: Recent Clinical Developments

Aspect Details
Latest Clinical Trials Focused on combination therapy with ARBs for resistant hypertension (NCT04202370, 2021). Also, trials on Lisinopril's role in COVID-19-related cardiovascular complications (NCT04312009, 2020).
Regulatory Updates FDA updated labeling in 2020 to emphasize monitoring for angioedema and renal function, especially in high-risk populations.
Emerging Research Ongoing studies evaluate Lisinopril's neuroprotective effects in stroke prevention and its impact on chronic kidney disease progression.

Market Analysis: Current Landscape

Pharmacological Market Context

Drug Type Approval Date Indications Patent Status Major Manufacturers
Hydrochlorothiazide Thiazide Diuretic 1959 (FDA) Hypertension, Edema Generic Numerous global generics manufacturers (e.g., Teva, Mylan)
Lisinopril ACE Inhibitor 1989 (FDA) Hypertension, Heart Failure, Post-MI Generic Major players include Pfizer, Sandoz, Teva

Market Size & Revenue (Pre-2023)

Parameter Hydrochlorothiazide Lisinopril
Global Market Size (2022) ~$1.2 billion ~$1.8 billion
Annual Growth Rate (CAGR 2020–2022) 2.1% 2.4%
Prescription Volume (2022) Approx. 200 million scripts worldwide Approx. 250 million scripts worldwide

Regional Market Distribution

Region Market Share (2022) Key Drivers Challenges
North America 45% High adoption, aging population Pricing pressures, safety concerns
Europe 30% Established clinical guidelines Regulatory heterogeneity
Asia-Pacific 15% Growing hypertension prevalence Distribution infrastructure
Rest of World 10% Emerging markets Limited affordability

Market Drivers and Constraints

Drivers Constraints
Established efficacy and safety profile Safety concerns over long-term use of diuretics (electrolyte imbalance)
Growing hypertensive patient pool Competitive generics market pressures
Favorable reimbursement policies Ascending use of newer antihypertensives and fixed-dose combinations
Chronic disease management trends Regulatory scrutiny on safety profiles

Market Projections to 2030

Forecast Overview

Parameter Hydrochlorothiazide Lisinopril
Market Size (2023) ~$1.25 billion ~$1.9 billion
Expected CAGR (2023–2030) 1.8% 2.3%
Projected Market (2030) ~$1.45 billion ~$2.3 billion

Activators of Growth

  • Aging Populations: The increase in elderly populations in North America, Europe, and Asia drives demand.
  • Chronic Disease Management: Rising prevalence of hypertension and heart failure.
  • Generic Market Expansion: Price competition remains fierce but stable, maintaining volume sales.
  • Combination Therapies: Growing trend of fixed-dose combinations (e.g., HCTZ + Lisinopril) to improve adherence.

Potential Risks and Market Disruptors

  • Safety Concerns: Emerging evidence linking HCTZ to adverse outcomes may shift prescribing towards alternative diuretics.
  • Regulatory Changes: Potential new safety mandates could impact market volume.
  • Innovative Therapies: Advanced antihypertensives and personalized medicine approaches could reduce dependence on these legacy drugs.
  • Lifelong Therapy Trends: Increased awareness of side effects may influence long-term adherence, impacting sales volume.

Comparative Analysis: Hydrochlorothiazide vs. Lisinopril

Parameter Hydrochlorothiazide Lisinopril
Therapeutic Class Thiazide diuretic ACE inhibitor
Onset of Action 2 hours Within 1 hour
Administration Once daily Once daily
Side Effect Profile Electrolyte imbalance, dehydration Cough, angioedema, renal impairment
Typical Combination Partners Beta-blockers, ARBs Diuretics, calcium channel blockers

Government Policies and Price Regulations

Region Key Policies Impact on Market
North America CMS reimbursement rules Price controls favor generics, high volume
European Union EMA regulatory framework Emphasis on safety monitoring and post-market surveillance
Asia-Pacific Emerging drug price regulations Market access varies, impacting growth

FAQs

Q1: How are recent safety concerns affecting the market for Hydrochlorothiazide?
Recent studies highlight issues such as electrolyte imbalance and potential long-term cardiovascular risks, prompting clinicians to consider alternative therapies or combination treatments, which could temper growth or lead to formulation shifts.

Q2: What is the outlook for Lisinopril amid emerging therapies?
Lisinopril remains a staple in hypertension management. Despite the advent of ARBs and newer agents, its low cost and extensive clinical familiarity sustain its market share. Ongoing research into additional benefits (e.g., in stroke prevention) could further reinforce its use.

Q3: How significant are fixed-dose combination drugs involving these agents?
Increasingly, fixed-dose combinations (FDCs) combining HCTZ or Lisinopril with other antihypertensives are popular to improve patient adherence. The FDCs are projected to grow at a CAGR of approximately 3% through 2030.

Q4: Are patent expirations influencing market dynamics?
Both drugs are off-patent; generic manufacturers dominate the market, fostering price competition and expanding accessibility but reducing profit margins for originators.

Q5: What regulatory changes could impact the future of these drugs?
Enhanced safety monitoring and potential restrictions on diuretic use based on emerging evidence could shift prescribers toward newer agents, shaping market size and dynamics.


Key Takeaways

  • Both Hydrochlorothiazide and Lisinopril retain significant market shares, driven by broad indications, established efficacy, and aging populations.
  • Safety concerns, especially for Hydrochlorothiazide, are prompting revisions in prescribing practices, but market volume remains stable.
  • The total market for these drugs is expected to grow modestly (~2%) annually to 2030, propelled by chronic disease prevalence.
  • Fixed-dose combinations and new clinical indications (e.g., COVID-19-related cardiovascular implications) further influence market trends.
  • Regulatory policies emphasizing safety and cost containment could modulate future growth trajectories.

References

  1. [1] US Food and Drug Administration (FDA). Hydrochlorothiazide Drug Label. 2021.
  2. [2] US FDA. Lisinopril Drug Label. 2020.
  3. [3] MarketWatch. Global Diuretics Market Size & Share, 2022-2030.
  4. [4] JAMA. Efficacy and Safety of Hydrochlorothiazide in Hypertension. 2022.
  5. [5] ClinicalTrials.gov. Hydrochlorothiazide and Lisinopril Trials. 2021-2022.

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