CLINICAL TRIALS PROFILE FOR HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL

All Clinical Trials for Hydrochlorothiazide And Olmesartan Medoxomil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00139698 ↗	Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension	Completed	Pfizer	Phase 3	2005-09-01	Efficacy, tolerability and safety of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension
NCT00171015 ↗	VALORY Study of Valsartan/Hydrochlorizide for Patients Who do Not Respond Adequately to Olmesartan Medoxomil	Completed	Novartis	Phase 3	2004-12-01	To evaluate the efficacy of valsartan 160 mg/HCTZ 25 mg in patients not adequately responding to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus HCTZ 12.5 mg by testing the hypothesis that valsartan 160 mg/HCTZ 25 mg significantly reduces the trough mean sitting diastolic blood pressure (MSDBP) after a 4-week treatment in the nonresponder population.
NCT00185068 ↗	An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension	Completed	Daiichi Sankyo Inc.	Phase 4	2004-03-01	Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension
NCT00185068 ↗	An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension	Completed	Daiichi Sankyo, Inc.	Phase 4	2004-03-01	Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension
NCT00185120 ↗	Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel Blocker	Completed	Daiichi Sankyo Inc.	Phase 4	2005-09-01	A comparison of 2 different combinations of high blood pressure medications to treat hypertension
NCT00185120 ↗	Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel Blocker	Completed	Daiichi Sankyo, Inc.	Phase 4	2005-09-01	A comparison of 2 different combinations of high blood pressure medications to treat hypertension
NCT00311155 ↗	Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension	Completed	Sankyo Pharma Gmbh	Phase 4	2006-03-01	This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

Clinical Trial Conditions for Hydrochlorothiazide And Olmesartan Medoxomil

Condition Name

Condition Name for Hydrochlorothiazide And Olmesartan Medoxomil
Intervention	Trials
Essential Hypertension	12
Hypertension	7
Healthy	2
Healthy Subjects	2

Condition MeSH

Condition MeSH for Hydrochlorothiazide And Olmesartan Medoxomil
Intervention	Trials
Hypertension	20
Essential Hypertension	13
Kidney Diseases	1
Systolic Murmurs	1

Clinical Trial Locations for Hydrochlorothiazide And Olmesartan Medoxomil

Trials by Country

Trials by Country for Hydrochlorothiazide And Olmesartan Medoxomil
Location	Trials
United States	150
Germany	16
Netherlands	10
Poland	8
Canada	5

Trials by US State

Trials by US State for Hydrochlorothiazide And Olmesartan Medoxomil
Location	Trials
Florida	6
California	6
Oklahoma	5
New York	5
Illinois	5

Clinical Trial Progress for Hydrochlorothiazide And Olmesartan Medoxomil

Clinical Trial Phase

Clinical Trial Phase for Hydrochlorothiazide And Olmesartan Medoxomil
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	15
Phase 1	5

Clinical Trial Status

Clinical Trial Status for Hydrochlorothiazide And Olmesartan Medoxomil
Clinical Trial Phase	Trials
Completed	25
Unknown status	1

Clinical Trial Sponsors for Hydrochlorothiazide And Olmesartan Medoxomil

Sponsor Name

Sponsor Name for Hydrochlorothiazide And Olmesartan Medoxomil
Sponsor	Trials
Daiichi Sankyo Inc.	9
Daiichi Sankyo, Inc.	9
Daiichi Sankyo Europe, GmbH	5

Sponsor Type

Sponsor Type for Hydrochlorothiazide And Olmesartan Medoxomil
Sponsor	Trials
Industry	46
Other	2

Hydrochlorothiazide And Olmesartan Medoxomil: Clinical Trials Update, Market Analysis and Projections

Last updated: April 28, 2026

What is the product and how is it positioned commercially?

Hydrochlorothiazide and olmesartan medoxomil is a fixed-dose combination (FDC) of:

• Olmesartan medoxomil (angiotensin II receptor blocker, ARB)
• Hydrochlorothiazide (thiazide diuretic)

Primary indication profile (market convention):

• Hypertension (adult), where combination therapy is used when monotherapy is insufficient.

Commercial position (typical FDC logic):

• ARB plus diuretic targets complementary mechanisms.
• The regimen targets patients who need add-on therapy and prefer fixed-dose dosing.

What is the clinical trial landscape right now?

No complete, verifiable, up-to-date clinical-trial dossier (trial registry status, trial identifiers, phase, enrollment, endpoints, completion status) was available in the provided information. Under the operating constraints, a complete and accurate “clinical trials update” cannot be produced without risking factual gaps.

Therefore: no clinical trial update is included.

What does the market look like today?

Market demand drivers

The combination is used in hypertension management where:

• Patients fail to reach target blood pressure on monotherapy.
• Clinicians use combination therapy early to improve control rates.
• ARB diuretic combinations are standard options within guidelines and formularies.

Channel and access pattern

For established antihypertensive FDCs:

• Uptake depends on formulary placement, payer step edits, and generic competition dynamics.
• Price erosion accelerates after major patent expiries and market-entry of generics/biosimilars-equivalents (for non-biologics: generic FDCs).

Competitive set (category-level)

The competitive set is not limited to direct FDC pairs. It includes:

• ARB + thiazide single-tablet equivalents from other manufacturers
• Alternative ARB + diuretic combinations
• ARB + calcium channel blocker and ACE inhibitor + diuretic FDCs (same treatment goal, different mechanism pairing)

No numeric market sizing or projection figures are included because they require current, citable datasets that were not provided.

What market projections are supportable?

No quantitative projection (market size, CAGR, unit volumes, price index, share movement, timeline to peak/recession, or scenario analysis) is supportable without cited, current market data and trial/patent status that were not supplied.

Therefore: no projections are included.

Key business implications for R&D, licensing, and investment

Even without numeric projections, decision logic for this class typically follows these verifiable patterns:

• Lifecycle risk: FDC markets face rapid volume shifts once generic entries expand at lower prices.
• Differentiation surface: If a portfolio includes a branded FDC, differentiation usually depends on dosing flexibility, safety/tolerability, and adherence outcomes versus generic equivalents.
• Regulatory strategy: For incremental development, the pathway is often driven by label expansion, fixed-dose optimization, and comparative bioavailability rather than novel mechanism claims.

Key Takeaways

• Hydrochlorothiazide and olmesartan medoxomil is an ARB plus thiazide fixed-dose combination used for adult hypertension.
• A complete, accurate clinical trials update cannot be produced from the information provided.
• A complete, accurate market analysis with numeric projections cannot be produced from the information provided.
• Decision work should focus on lifecycle stage, payer access dynamics, and generic-entry pressure typical for established antihypertensive FDCs.

FAQs

1. Is hydrochlorothiazide plus olmesartan medoxomil a fixed-dose combination?
   Yes. It is a fixed-dose combination of an ARB (olmesartan medoxomil) and a thiazide diuretic (hydrochlorothiazide).

2. What indication does the combination target?
   It is used for adult hypertension, typically when combination therapy is needed for blood pressure control.

3. What determines commercial performance for this type of drug?
   Formulary placement, payer step therapy, price erosion from generic FDC entries, and patient adherence via single-tablet dosing.

4. Why can’t a clinical trials update be listed here?
   A precise, current clinical-trial status requires trial identifiers, phases, enrollment numbers, and endpoints from registries, none of which were provided.

5. Why can’t numeric market projections be shown here?
   Market sizing and forecast modeling require current, citable market data and lifecycle context, none of which were provided.

References

[1] FDA. Drug Approval Reports for olmesartan medoxomil and hydrochlorothiazide (fixed-dose combination labeling).
[2] EMA. Product information for olmesartan medoxomil combinations with hydrochlorothiazide.
[3] ClinicalTrials.gov. Search results for “olmesartan medoxomil hydrochlorothiazide” (trial listings and status).
[4] WHOCC. ATC classification for olmesartan (C09CA) and hydrochlorothiazide (C03AA) and combination classification.