CLINICAL TRIALS PROFILE FOR HYDROCHLOROTHIAZIDE; LISINOPRIL

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 (
NCT00459056 ↗	The Vascular Effects of Carvedilol Controlled Release (CR) in Abdominally Obese Hypertensive Patients	Completed	GlaxoSmithKline	Phase 3	2007-04-01	The purpose of this study is to compare the effects of two different combination therapies for high blood pressure on vascular health.

Clinical Trial Conditions for HYDROCHLOROTHIAZIDE; LISINOPRIL

Condition Name

Condition Name for HYDROCHLOROTHIAZIDE; LISINOPRIL
Intervention	Trials
Hypertension	8
Fasting	1
Fed	1
Hypertension in Pregnancy	1

Condition MeSH

Condition MeSH for HYDROCHLOROTHIAZIDE; LISINOPRIL
Intervention	Trials
Hypertension	8
Diabetes Mellitus, Type 2	1
Glucose Intolerance	1
Cognitive Dysfunction	1

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

Trials by US State

Trials by US State for HYDROCHLOROTHIAZIDE; LISINOPRIL
Location	Trials
California	4
Texas	2
Michigan	2
Massachusetts	2
New Jersey	2

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

Clinical Trial Status

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Withdrawn	1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

Clinical Trial Sponsors for HYDROCHLOROTHIAZIDE; LISINOPRIL

Sponsor Name

Sponsor Name for HYDROCHLOROTHIAZIDE; LISINOPRIL
Sponsor	Trials
IPCA Laboratories Ltd.	2
US Department of Veterans Affairs	1
Novartis Pharmaceuticals	1

Sponsor Type

Sponsor Type for HYDROCHLOROTHIAZIDE; LISINOPRIL
Sponsor	Trials
Other	8
Industry	7
U.S. Fed	2

HYDROCHLOROTHIAZIDE; LISINOPRIL Market Analysis and Financial Projection

Last updated: April 25, 2026

Clinical Trials Update, Market Analysis and Projection: Hydrochlorothiazide (HCTZ) + Lisinopril

What is the current clinical-trials state for hydrochlorothiazide + lisinopril?

No specific, active “hydrochlorothiazide plus lisinopril” combination clinical trial set (by protocol status, dates, enrollment, and outcomes) is identifiable from the information available in this request.

Which regulatory and evidence framework most influences the combination’s clinical positioning?

The drug pair is primarily treated as a fixed-dose antihypertensive regimen built from well-established monotherapies:

• Lisinopril (ACE inhibitor) is used for hypertension and other cardiovascular indications.
• Hydrochlorothiazide (thiazide diuretic) is used for hypertension and is frequently paired with ACE inhibitors in clinical practice.

Because this request does not provide a target company, brand, dose strength(s), or route/formulation, a combination-specific trial line cannot be mapped to a defined development program without risking incorrect attribution.

What does the market look like for HCTZ + lisinopril, as a category?

The category is “generic antihypertensive combination therapy,” driven by:

• Long-standing standard-of-care use of ACE inhibitor + thiazide combinations for hypertension.
• Competitive pricing pressure from generic entries.
• Ongoing demand in chronic management rather than patent-defined high-margin innovation.

Given missing combination-specific product identifiers, the only safe market framing is category-level dynamics:

• Volume-driven revenue model typical of generics.
• Formulary access and payer contracting as key determinants of share.
• Switching and adherence (fixed-dose vs free-combination) as the primary commercial levers.

What market projection can be stated without product-level identifiers?

A precise, investment-grade projection requires at least: (1) specific fixed-dose strengths and route, (2) geography, (3) revenue definition (sales vs prescriptions), and (4) horizon (e.g., 2028 or 2030). Those inputs are not provided, so no complete and accurate projection can be produced.

How do clinical and payer incentives typically shape uptake of the combination?

In antihypertensive therapy, uptake patterns generally follow:

• Line-of-therapy behavior: ACE inhibitor + thiazide combinations often appear early when monotherapy fails to reach goal.
• Adherence economics: Fixed-dose combinations reduce pill burden versus separate tablets, supporting formulary and step-therapy outcomes.
• Safety monitoring workflow: Diuretic and ACE inhibitor classes require monitoring for electrolytes, renal function, and tolerability. This reduces adoption in populations with high monitoring complexity but strengthens adoption where monitoring infrastructure exists.

What competitive landscape constraints matter most?

The combination competes within the broad class of:

• ACE inhibitor + thiazide fixed-dose generics
• ACE inhibitor + other diuretic combinations
• ARB + thiazide options
• Calcium channel blocker-based regimens

Competitive share typically turns on:

• Lowest net price through contracting
• Preferred formulary status
• Tablet strength coverage (dose flexibility)
• Manufacturing reliability and supply continuity

What can be concluded about pipeline and innovation risk?

For HCTZ + lisinopril:

• Patent-driven pipeline disruption is usually limited because both molecules are long off-patent in most jurisdictions.
• Differentiation is typically manufacturing, packaging, and line-extension rather than new clinical mechanisms.
• Any “new trial update” that matters commercially would need to map to a specific brand’s label expansion, formulation change, or new indication. No such program can be verified from the request.

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Key Takeaways

• This request does not contain enough product- or program-level information to produce a complete, accurate “clinical trials update” for the specific HCTZ + lisinopril combination.
• Category economics favor a volume-driven generic antihypertensive regimen shaped by formularies, net pricing, and adherence.
• A numeric market projection is not supportable without specifying geography, time horizon, and the exact fixed-dose product definition.

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FAQs

1. Is hydrochlorothiazide + lisinopril still used as a standard hypertension regimen?
   Yes. The clinical pairing of an ACE inhibitor with a thiazide diuretic remains a common standard approach in hypertension management.

2. Are there meaningful new clinical-trials results expected for this specific combination?
   The request does not identify any specific ongoing or completed combination trials that can be reported with protocol-level accuracy.

3. What drives market share for HCTZ + lisinopril products?
   Formulary position, net price from contracting, fixed-dose strength coverage, and supply reliability.

4. How does safety monitoring influence adoption?
   ACE inhibitor and thiazide therapy typically require monitoring for renal function and electrolytes, which affects tolerability and prescribing patterns in higher-risk populations.

5. What is the typical investment thesis for this class?
   Operations and distribution execution rather than patent protection, because market outcomes depend heavily on generic competitiveness and contracting.

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References

1. FDA. (n.d.). Drug safety communications and labeling for ACE inhibitors and thiazide diuretics. U.S. Food and Drug Administration.
2. EMA. (n.d.). Product information and pharmacovigilance for ACE inhibitors and thiazide diuretics. European Medicines Agency.
3. ClinicalTrials.gov. (n.d.). Search results for hydrochlorothiazide and lisinopril (combination-specific terms). U.S. National Library of Medicine.