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.

Clinical Trial Conditions for HYDROCHLOROTHIAZIDE; IRBESARTAN

Condition Name

Condition Name for HYDROCHLOROTHIAZIDE; IRBESARTAN
Intervention	Trials
Hypertension	14
Healthy	1
Metabolic Syndrome	1
Microalbuminuria	1

Condition MeSH

Condition MeSH for HYDROCHLOROTHIAZIDE; IRBESARTAN
Intervention	Trials
Hypertension	13
Syndrome	1
Metabolic Syndrome X	1
Metabolic Syndrome	1

Clinical Trial Locations for HYDROCHLOROTHIAZIDE; IRBESARTAN

Trials by Country

Trials by Country for HYDROCHLOROTHIAZIDE; IRBESARTAN
Location	Trials
United States	71
Canada	18
Germany	6
Taiwan	4
France	4

Trials by US State

Trials by US State for HYDROCHLOROTHIAZIDE; IRBESARTAN
Location	Trials
Texas	4
Massachusetts	2
Maryland	2
Louisiana	2
Illinois	2

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

Clinical Trial Status

Clinical Trial Status for HYDROCHLOROTHIAZIDE; IRBESARTAN
Clinical Trial Phase	Trials
Completed	15
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for HYDROCHLOROTHIAZIDE; IRBESARTAN

Sponsor Name

Sponsor Name for HYDROCHLOROTHIAZIDE; IRBESARTAN
Sponsor	Trials
Sanofi	10
Bristol-Myers Squibb	4
Roxane Laboratories	2

Sponsor Type

Sponsor Type for HYDROCHLOROTHIAZIDE; IRBESARTAN
Sponsor	Trials
Industry	16
Other	6

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