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Last Updated: July 8, 2025

CLINICAL TRIALS PROFILE FOR LISINOPRIL AND HYDROCHLOROTHIAZIDE


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All Clinical Trials for Lisinopril 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.
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 (<140/90 mmHg). Follow-up will last 2 years. Blood sample and urine analyses, carotid and cardiac ultrasound will be performed at baseline and scheduled time points. Genotyping will be performed by sequencing. Data will be collected and stored using a web based centralized Case Report Form (CRF) Expected results: Results will highlight whether a follow-up strategy based on tight cooperation between GPs and HT specialists can allow the use of thiazides as first line antihypertensive therapy without any negative effect on persistence, adherence and efficacy of the treatment. These data can be used to reduce total burden of the Health Care System in HT by replacing more expensive drugs with diuretics in the 50% of hypertensive patients, who do not receive this class of drugs. Furthermore, the pharmacogenetic approach may clarify the pathophysiological mechanisms of drug-induced metabolic side effects
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 (<140/90 mmHg). Follow-up will last 2 years. Blood sample and urine analyses, carotid and cardiac ultrasound will be performed at baseline and scheduled time points. Genotyping will be performed by sequencing. Data will be collected and stored using a web based centralized Case Report Form (CRF) Expected results: Results will highlight whether a follow-up strategy based on tight cooperation between GPs and HT specialists can allow the use of thiazides as first line antihypertensive therapy without any negative effect on persistence, adherence and efficacy of the treatment. These data can be used to reduce total burden of the Health Care System in HT by replacing more expensive drugs with diuretics in the 50% of hypertensive patients, who do not receive this class of drugs. Furthermore, the pharmacogenetic approach may clarify the pathophysiological mechanisms of drug-induced metabolic side effects
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lisinopril And Hydrochlorothiazide

Condition Name

Condition Name for Lisinopril And Hydrochlorothiazide
Intervention Trials
Hypertension 8
Fasting 1
Fed 1
Hypertension in Pregnancy 1
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Condition MeSH

Condition MeSH for Lisinopril And Hydrochlorothiazide
Intervention Trials
Hypertension 8
Essential Hypertension 1
Malnutrition 1
Diabetes Mellitus, Type 2 1
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Clinical Trial Locations for Lisinopril And Hydrochlorothiazide

Trials by Country

Trials by Country for Lisinopril And Hydrochlorothiazide
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 Lisinopril And Hydrochlorothiazide
Location Trials
California 4
Florida 2
Texas 2
Michigan 2
Massachusetts 2
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Clinical Trial Progress for Lisinopril And Hydrochlorothiazide

Clinical Trial Phase

Clinical Trial Phase for Lisinopril And Hydrochlorothiazide
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Lisinopril And Hydrochlorothiazide
Clinical Trial Phase Trials
Completed 10
Withdrawn 1
Recruiting 1
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Clinical Trial Sponsors for Lisinopril And Hydrochlorothiazide

Sponsor Name

Sponsor Name for Lisinopril And Hydrochlorothiazide
Sponsor Trials
IPCA Laboratories Ltd. 2
University of Southern California 1
Forest Laboratories 1
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Sponsor Type

Sponsor Type for Lisinopril And Hydrochlorothiazide
Sponsor Trials
Other 8
Industry 7
U.S. Fed 2
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Lisinopril and Hydrochlorothiazide: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Lisinopril and hydrochlorothiazide is a combination medication used to treat high blood pressure (hypertension) by combining the effects of an angiotensin-converting enzyme (ACE) inhibitor and a thiazide diuretic. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Comparative Studies

A 52-week study compared the antihypertensive efficacy and safety of lisinopril, hydrochlorothiazide (HCTZ), and their combination in patients with high blood pressure. The study found that the combination of lisinopril and HCTZ was more effective than either drug alone in controlling diastolic blood pressure. Specifically, the combination controlled blood pressure in 11 out of 13 patients, whereas lisinopril alone controlled it in 8 out of 10 patients, and HCTZ alone in 3 out of 10 patients[4].

Safety Profile

The same study noted that while side effects were more frequent in patients receiving the combination, they were generally mild and subsided spontaneously. Lisinopril was found to be more effective as a step-1 drug compared to HCTZ, and the combination was superior to either agent alone[4].

Mechanism of Action

Lisinopril

Lisinopril is an ACE inhibitor that works by blocking the formation of angiotensin II, a substance that causes blood vessels to tighten. By inhibiting this substance, lisinopril relaxes the blood vessels, lowers blood pressure, and increases the supply of blood and oxygen to the heart[1][5].

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic that reduces the amount of water in the body by increasing the flow of urine. This helps lower blood pressure by reducing the volume of blood in the arteries[1][5].

Market Analysis

Current Market Size

The lisinopril market, which includes the combination of lisinopril and hydrochlorothiazide, was valued at approximately $1.66 billion in 2023. This market is expected to grow to $1.76 billion in 2024, with a compound annual growth rate (CAGR) of 6.0%[2].

Growth Drivers

Several factors are driving the growth of the lisinopril market:

  • Increasing Prevalence of Hypertension and Cardiovascular Diseases: The rising prevalence of hypertension and cardiovascular diseases, such as coronary heart disease, is a significant driver. For instance, the World Health Organization reported that around 1.28 billion adults aged 30-79 worldwide had hypertension in 2023[2][3].
  • Aging Population: The growing aging population contributes to the increased demand for effective treatments for hypertension and heart failure[2][3].
  • Innovations in Drug Delivery: Advances in drug delivery systems, such as nanotechnology-based formulations, are expected to enhance the bioavailability and efficacy of lisinopril, further driving market growth[3].

Regional Market

North America was the largest region in the lisinopril market in 2023, while the Asia-Pacific region is expected to be the fastest-growing region in the forecast period. The market is also significant in other regions, including Western Europe, Eastern Europe, South America, the Middle East, and Africa[2].

Market Projections

Future Growth

The lisinopril market is projected to continue growing strongly. By 2028, the market is expected to reach $2.26 billion, with a CAGR of 6.4% from 2024 to 2028. By 2032, the market is estimated to grow at a CAGR of 4.8%, reaching a size of around $2.5 billion[2][3].

Market Segments

The market is segmented based on dosage forms (tablets and liquids), dosage strengths (10 mg, 20 mg, 25 mg), patient age groups (children and adults), applications (hypertension, heart failure, heart attack, diabetic kidney disease), and distribution channels (hospital pharmacy, retail pharmacy, online pharmacy). The tablet segment and the 20 mg dosage strength are expected to dominate the market[3].

Distribution and Usage

Dosage and Administration

Lisinopril and hydrochlorothiazide are typically taken once daily, either with or without food. Patients are advised to take the medication at the same time every day to maintain a consistent blood pressure control. The medication should be taken exactly as directed by the doctor, and patients should not stop taking it without consulting their healthcare provider[5].

Distribution Channels

The hospital pharmacy segment is expected to account for a significant portion of the market revenue, followed by retail and online pharmacies. The convenience and accessibility of these distribution channels contribute to the market's growth[3].

Side Effects and Precautions

Common Side Effects

While generally well-tolerated, lisinopril and hydrochlorothiazide can cause side effects such as swelling, hoarseness, difficulty breathing, stomach pain, and muscle weakness. Serious side effects include swelling of the face, throat, or tongue, and difficulty breathing or swallowing[5].

Special Precautions

Patients with certain conditions, such as glaucoma, gout, heart or blood vessel disease, liver disease, or systemic lupus erythematosus, should use this medication with caution. Additionally, elderly patients may require dose adjustments due to age-related kidney, liver, or heart problems[1].

Key Takeaways

  • Efficacy: The combination of lisinopril and hydrochlorothiazide is more effective than either drug alone in controlling high blood pressure.
  • Market Growth: The lisinopril market is driven by the increasing prevalence of hypertension and cardiovascular diseases, an aging population, and innovations in drug delivery.
  • Future Projections: The market is expected to grow significantly, reaching $2.26 billion by 2028 and continuing to grow at a CAGR of 4.8% until 2032.
  • Distribution: The medication is available through various distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies.
  • Side Effects: While generally safe, the medication can cause side effects, and certain precautions should be taken by patients with specific health conditions.

FAQs

What is the primary use of lisinopril and hydrochlorothiazide?

Lisinopril and hydrochlorothiazide are used to treat high blood pressure (hypertension) by combining the effects of an ACE inhibitor and a thiazide diuretic.

How does lisinopril work?

Lisinopril works by blocking the formation of angiotensin II, a substance that causes blood vessels to tighten, thereby relaxing the blood vessels and lowering blood pressure.

What are the common side effects of lisinopril and hydrochlorothiazide?

Common side effects include swelling, hoarseness, difficulty breathing, stomach pain, and muscle weakness. Serious side effects can include swelling of the face, throat, or tongue, and difficulty breathing or swallowing.

Which regions are expected to drive the growth of the lisinopril market?

North America is currently the largest region, while the Asia-Pacific region is expected to be the fastest-growing region in the forecast period.

What are the key drivers of the lisinopril market growth?

The key drivers include the increasing prevalence of hypertension and cardiovascular diseases, an aging population, and innovations in drug delivery systems.

Can lisinopril and hydrochlorothiazide be used in pediatric patients?

The safety and efficacy of lisinopril and hydrochlorothiazide have not been established in the pediatric population, so it is not recommended for children without specific medical guidance.

Sources

  1. Mayo Clinic: Lisinopril and hydrochlorothiazide (oral route) - Mayo Clinic.
  2. GII Research: Lisinopril Global Market Report 2024.
  3. GMI Insights: Lisinopril Market Size & Share – Trends Report, 2032.
  4. PubMed: A 52-week comparison of lisinopril, hydrochlorothiazide, and their combination.
  5. MedlinePlus: Lisinopril and Hydrochlorothiazide: MedlinePlus Drug Information.

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