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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE


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All Clinical Trials for Olmesartan Medoxomil And Hydrochlorothiazide

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Olmesartan Medoxomil And Hydrochlorothiazide

Condition Name

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

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

Trials by Country

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

Trials by US State for Olmesartan Medoxomil And Hydrochlorothiazide
Location Trials
Florida 6
California 6
Illinois 5
Texas 5
Ohio 5
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Clinical Trial Progress for Olmesartan Medoxomil And Hydrochlorothiazide

Clinical Trial Phase

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

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

Sponsor Name

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

Sponsor Type for Olmesartan Medoxomil And Hydrochlorothiazide
Sponsor Trials
Industry 46
Other 2
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Olmesartan Medoxomil and Hydrochlorothiazide: Clinical Trials, Market Analysis, and Projections

Introduction

Olmesartan medoxomil and hydrochlorothiazide is a combination drug used to treat hypertension. This article will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

Efficacy of Olmesartan Medoxomil and Hydrochlorothiazide

Clinical trials have consistently shown the efficacy of olmesartan medoxomil and hydrochlorothiazide in reducing blood pressure. A double-blind, active-controlled trial involving 2,492 hypertensive patients demonstrated that the combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide produced greater reductions in both systolic and diastolic blood pressures compared to dual combination therapies[1].

In another study, the combination of olmesartan medoxomil and hydrochlorothiazide was compared to monotherapy with either component. The results showed that all olmesartan medoxomil/HCTZ combinations significantly reduced seated diastolic and systolic blood pressures in a dose-dependent manner, with reductions of up to 26.8/21.9 mm Hg[5].

Safety and Tolerability

The safety profile of olmesartan medoxomil and hydrochlorothiazide has been evaluated in several trials. In a controlled trial, 574 patients received the combination therapy for 8 weeks, with a discontinuation rate due to adverse events of 4%. Common adverse reactions included dizziness, peripheral edema, headache, and fatigue[1].

A clinical trial comparing the long-term safety and tolerability of azilsartan medoxomil and chlorthalidone to olmesartan medoxomil and hydrochlorothiazide in patients with hypertension and moderate renal impairment also highlighted the safety of the latter combination[3].

Mechanism of Action

The combination of olmesartan medoxomil, an angiotensin II receptor blocker, and hydrochlorothiazide, a diuretic, targets two separate mechanisms involved in blood pressure regulation. Olmesartan medoxomil blocks the action of angiotensin II, a potent vasoconstrictor, while hydrochlorothiazide increases urine production, reducing blood volume and pressure[1].

Market Analysis

Market Size and Growth

The global market for olmesartan medoxomil and hydrochlorothiazide tablets is analyzed in terms of market size, trends, and demand forecasts. The market is expected to grow due to increasing prevalence of hypertension and the need for effective combination therapies. The report by QYResearch provides detailed market data breakdowns by type, application, company, and region, as well as competitive landscape and key company profiles[2].

Regional Market Performance

The market performance varies by region, with significant sales in Asia, Middle East, Africa, and Latin America. The report highlights sales by region, type, and application, providing insights into the market's growth potential and challenges[2].

Competitive Landscape

The competitive landscape includes both original and generic manufacturers. Major manufacturers are profiled in the report, providing an overview of their market share and strategies. The presence of generic versions of the drug also influences the market dynamics, offering cost-effective alternatives to patients[2].

Projections and Future Outlook

Market Growth Projections

The market for olmesartan medoxomil and hydrochlorothiazide tablets is projected to continue growing, driven by the increasing demand for antihypertensive medications. The report forecasts market size and growth rates up to 2030, indicating a positive outlook for this combination therapy[2].

Emerging Trends

Emerging trends in the antihypertensive market include the development of new combination therapies and the increasing focus on patient compliance and adherence. The combination of olmesartan medoxomil and hydrochlorothiazide is likely to remain a significant player in this market due to its proven efficacy and safety profile[1][4].

Key Takeaways

  • Efficacy: Olmesartan medoxomil and hydrochlorothiazide combination therapy has been shown to significantly reduce blood pressure in clinical trials.
  • Safety: The combination is generally well-tolerated, with common adverse reactions including dizziness and peripheral edema.
  • Market Growth: The global market for this combination is expected to grow, driven by increasing demand for effective antihypertensive therapies.
  • Regional Performance: The market performs well in various regions, including Asia, Middle East, Africa, and Latin America.
  • Competitive Landscape: The market includes both original and generic manufacturers, with significant competition influencing market dynamics.

FAQs

Q: What is the mechanism of action of olmesartan medoxomil and hydrochlorothiazide?

A: Olmesartan medoxomil blocks the action of angiotensin II, a potent vasoconstrictor, while hydrochlorothiazide increases urine production, reducing blood volume and pressure[1].

Q: What were the results of the clinical trials for this combination therapy?

A: Clinical trials showed that the combination of olmesartan medoxomil and hydrochlorothiazide significantly reduced blood pressure compared to monotherapy or dual combination therapies[1][5].

Q: What are the common adverse reactions associated with this combination therapy?

A: Common adverse reactions include dizziness, peripheral edema, headache, and fatigue[1].

Q: What is the market outlook for olmesartan medoxomil and hydrochlorothiazide tablets?

A: The market is projected to grow, driven by increasing demand for effective antihypertensive therapies, with forecasts indicating positive growth up to 2030[2].

Q: Are there any emerging trends in the antihypertensive market that could impact this combination therapy?

A: Emerging trends include the development of new combination therapies and a focus on patient compliance and adherence, which could influence the market dynamics but are likely to support the continued use of this combination therapy[1][4].

Sources

  1. Managed Healthcare Executive: "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide (Tribenzor) new 3-drug combination product."
  2. QYResearch: "Global Olmesartan Medoxomil Hydrochlorothiazide Tablets Market."
  3. ClinicalTrials.takeda: "Long-Term Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Hypertension and Kidney Disease."
  4. SAGE Journals: "Olmesartan/amlodipine: blood pressure lowering and beyond in hypertensive patients."
  5. PubMed: "Evaluation of antihypertensive therapy with the combination of olmesartan medoxomil and hydrochlorothiazide."

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