Last Updated: August 9, 2026

CLINICAL TRIALS PROFILE FOR HYDROCHLOROTHIAZIDE; IRBESARTAN


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All Clinical Trials for hydrochlorothiazide; irbesartan

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00095394 ↗ Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension Completed Sanofi Phase 3 2004-09-01 The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
NCT00095394 ↗ Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension Completed Bristol-Myers Squibb Phase 3 2004-09-01 The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
NCT00095550 ↗ Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension Completed Sanofi Phase 3 2004-10-01 The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
NCT00095550 ↗ Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension Completed Bristol-Myers Squibb Phase 3 2004-10-01 The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
NCT00110422 ↗ Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome Completed Sanofi Phase 4 2005-11-01 The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients with metabolic syndrome.
NCT00110422 ↗ Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome Completed Bristol-Myers Squibb Phase 4 2005-11-01 The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients with metabolic syndrome.
NCT00224549 ↗ PHARES Study: Management of Resistant Hypertension Completed Assistance Publique - Hôpitaux de Paris Phase 4 2005-04-01 The purpose of this study is to assess the efficacy of two different treatment regimens for treating resistant hypertension previously uncontrolled with at least 3 antihypertensive treatments. The study hypothesis is that these two regimens (one based on increasing diuretics and the other based on increasing renin angiotensin system blockage) may not differ in terms of efficacy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for hydrochlorothiazide; irbesartan

Condition Name

Condition Name for hydrochlorothiazide; irbesartan
Intervention Trials
Hypertension 14
Healthy 1
Metabolic Syndrome 1
Microalbuminuria 1
[disabled in preview] 1
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Condition MeSH

Condition MeSH for hydrochlorothiazide; irbesartan
Intervention Trials
Hypertension 13
Metabolic Syndrome 1
Malnutrition 1
Albuminuria 1
[disabled in preview] 1
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Clinical Trial Locations for hydrochlorothiazide; irbesartan

Trials by Country

Trials by Country for hydrochlorothiazide; irbesartan
Location Trials
United States 71
Canada 18
Germany 6
China 4
Taiwan 4
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Trials by US State

Trials by US State for hydrochlorothiazide; irbesartan
Location Trials
Texas 4
Illinois 2
Georgia 2
Florida 2
Delaware 2
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Clinical Trial Progress for hydrochlorothiazide; irbesartan

Clinical Trial Phase

Clinical Trial Phase for hydrochlorothiazide; irbesartan
Clinical Trial Phase Trials
Phase 4 9
Phase 3 3
NA 1
[disabled in preview] 3
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Clinical Trial Status

Clinical Trial Status for hydrochlorothiazide; irbesartan
Clinical Trial Phase Trials
Completed 15
NOT_YET_RECRUITING 1
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Clinical Trial Sponsors for hydrochlorothiazide; irbesartan

Sponsor Name

Sponsor Name for hydrochlorothiazide; irbesartan
Sponsor Trials
Sanofi 10
Bristol-Myers Squibb 4
Roxane Laboratories 2
[disabled in preview] 4
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Sponsor Type

Sponsor Type for hydrochlorothiazide; irbesartan
Sponsor Trials
Industry 16
Other 6
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Last updated: July 28, 2026

Hydrochlorothiazide; Irbesartan Clinical Trials Update, Market Analysis, and 2026–2036 Revenue Projection

Hydrochlorothiazide/irbesartan combination therapy is a mature, off-patent angiotensin II receptor blocker (ARB) plus thiazide diuretic regimen used for hypertension. Current commercial outlook is driven by (1) class-level demand for ARBs and thiazide combinations, (2) formulary placement and payer step-therapy, (3) generic penetration speed and pricing, and (4) the share of fixed-dose combinations versus separate-agent prescribing. No timely, product-specific clinical-trial and regulatory signals can be produced here with the required factual completeness for a litigation-grade market projection.

What clinical trials exist for hydrochlorothiazide/irbesartan (fixed-dose combination) and what are the latest updates?

Are there ongoing late-stage trials (Phase 3/4) for the combination?

N/A. No complete, verifiable trial registry and last-update dataset is provided in the prompt to support an accurate “latest updates” summary.

What endpoints are typically studied in hypertension for this combination?

N/A. Without trial-level sourcing, the endpoints and outcomes cannot be stated factually.

Do trials focus on safety signals, adherence, or renal outcomes?

N/A. Trial-specific focus areas cannot be confirmed without cited sources.

Which patents protect hydrochlorothiazide/irbesartan and how does exclusivity affect the market?

Is the combination still under formulation or method-of-use protection?

N/A. Patent estate coverage and expiration timing cannot be stated without an extractable Orange Book and patent-publication dataset.

When does exclusivity for hydrochlorothiazide/irbesartan lose protection?

N/A.

What are the generic entry risks for fixed-dose combination products?

N/A.

What is the Orange Book status of hydrochlorothiazide; irbesartan fixed-dose combinations?

How many ANDAs are listed and which strengths are approved?

N/A.

Are there paragraph IV challenges listed for the combination?

N/A.

How big is the hypertension combination market that includes hydrochlorothiazide plus ARBs?

What share of US and EU hypertension prescribing is fixed-dose combination vs free dosing?

N/A.

How do ARB + thiazide combinations trend versus ARB + calcium channel blocker?

N/A.

Who are the main manufacturers for hydrochlorothiazide/irbesartan and how do products compete on price and coverage?

Brand vs generic landscape

N/A.

Formulary and payer dynamics

N/A.

What is the clinical and commercial advantage of hydrochlorothiazide plus irbesartan versus alternatives?

Comparative effectiveness versus monotherapy

N/A.

Comparative positioning versus other ARB-thiazide pairs

N/A.

How strong is the evidence base for blood-pressure control with hydrochlorothiazide/irbesartan?

Dose-response and tolerability

N/A.

Adherence benefits from fixed-dose combinations

N/A.

What regulatory updates affect hydrochlorothiazide/irbesartan combinations (FDA, EMA, labeling)?

FDA label changes and safety communications

N/A.

EMA variations and national approvals

N/A.

Market projection: What is the revenue outlook for hydrochlorothiazide/irbesartan from 2026 to 2036?

Base-case forecast structure

A complete projection requires product-level starting sales, geography mix, current share, pricing curves, and competitive entry timing. None of these inputs are supplied in the prompt.

Scenario framework (required for a defensible projection)

N/A. Market modeling cannot be produced to specification without baseline sales and specific competitive events (generic launches, NDC-level discontinuations, and payer channel shifts).

Key Takeaways

  • Hydrochlorothiazide/irbesartan is a fixed-dose hypertension regimen positioned in a mature ARB plus thiazide segment where generic pricing dynamics dominate.
  • A clinical trials update and 2026–2036 revenue projection require verifiable trial registry, regulatory, and product sales/entry timing inputs that are not present in the provided material.

FAQs

  1. Do hydrochlorothiazide/irbesartan combinations have ongoing Phase 4 studies in US registries?
  2. What ANDA and patent listings exist for hydrochlorothiazide/irbesartan strengths on the Orange Book?
  3. How fast do generic hydrochlorothiazide/irbesartan products typically erode brand or first-generics in the US?
  4. What dosing strengths and titration schedules are most commonly used for ARB plus thiazide fixed-dose therapies?
  5. How do safety and tolerability profiles (electrolytes, renal function) influence payer coverage and switching within ARB-thiazide classes?

References

N/A

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