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Last Updated: January 21, 2025

CLINICAL TRIALS PROFILE FOR HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL


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All Clinical Trials for Hydrochlorothiazide; 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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hydrochlorothiazide; Olmesartan Medoxomil

Condition Name

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

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

Trials by Country

Trials by Country for Hydrochlorothiazide; Olmesartan Medoxomil
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 Hydrochlorothiazide; Olmesartan Medoxomil
Location Trials
Florida 6
California 6
Illinois 5
Texas 5
Ohio 5
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Clinical Trial Progress for Hydrochlorothiazide; Olmesartan Medoxomil

Clinical Trial Phase

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

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

Sponsor Name

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

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

Introduction

The combination of hydrochlorothiazide (HCTZ) and olmesartan medoxomil is a widely used treatment for hypertension. This article delves into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Purpose and Design

Clinical trials involving HCTZ and olmesartan medoxomil are designed to evaluate their efficacy, safety, and tolerability. For instance, a clinical trial conducted from March 2011 to October 2012 compared the long-term safety and tolerability of azilsartan medoxomil and chlorthalidone with olmesartan medoxomil and HCTZ in participants with hypertension and moderate renal impairment[1].

Key Findings

  • Blood Pressure Reduction: Studies have shown that the combination of olmesartan medoxomil and HCTZ is effective in reducing both systolic and diastolic blood pressure. For example, the combination of 40/25mg of olmesartan medoxomil and HCTZ reduced systolic and diastolic blood pressure by 26.8 and 15.5 mm Hg, respectively[5].
  • Tolerability and Safety: The combination is generally well-tolerated, with an incidence of adverse events similar to those seen with angiotensin II receptor blocker (ARB) monotherapy. Clinical trials have also evaluated the bioequivalence and dose proportionality of the combination, ensuring that the drug's effects are consistent across different dosage strengths[3].

Secondary Outcome Measures

Clinical trials often include secondary outcome measures such as the percentage of participants achieving target blood pressure levels. For instance, one trial measured the percentage of participants who achieved target systolic and diastolic blood pressure levels (<130 mm Hg and <80 mm Hg, respectively) at the final visit[1].

Mechanism of Action

Olmesartan Medoxomil

Olmesartan medoxomil is an ARB that works by blocking the action of angiotensin II, a substance in the body that causes blood vessels to tighten. By blocking this substance, olmesartan medoxomil relaxes the blood vessels, lowering blood pressure and increasing the supply of blood and oxygen to the heart[4].

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic that reduces the amount of water in the body by increasing urine production. This reduction in fluid volume helps lower blood pressure[4].

Market Analysis

Market Size and Growth

The global market for olmesartan medoxomil and HCTZ tablets is analyzed based on market size, trends, and demand forecasts. The market is expected to grow due to increasing prevalence of hypertension and the need for effective antihypertensive treatments. According to market research, the global olmesartan medoxomil and HCTZ tablets market is segmented by type, application, company, and region, providing a comprehensive view of the competitive landscape and key company profiles[2].

Regional Breakdown

The market is broken down by region, including North America, Europe, Asia, and the Middle East, Africa, and Latin America. Each region's market size, growth rate, and revenue share are analyzed to provide a detailed understanding of the global market dynamics[2].

Competitive Landscape

The competitive landscape includes major manufacturers of both original and generic versions of the drug. The report highlights key company profiles and their market share, helping to identify market leaders and emerging players[2].

Projections and Future Outlook

Market Growth Projections

The global olmesartan medoxomil and HCTZ tablets market is projected to continue growing, driven by increasing demand for antihypertensive medications. The market is expected to expand in various regions, with Asia and Latin America showing significant growth potential due to rising healthcare expenditures and an increasing awareness of hypertension management[2].

Emerging Trends

Emerging trends in the market include the development of generic versions of the drug, which are expected to increase accessibility and affordability. Additionally, advancements in formulation technology and the introduction of new dosage forms may further enhance the market[2].

Regulatory Considerations

Regulatory approvals and compliance will continue to play a crucial role in the market. Manufacturers must ensure that their products meet stringent regulatory standards, and any changes in regulatory policies could impact market dynamics[3].

Key Takeaways

  • Clinical Efficacy: The combination of olmesartan medoxomil and HCTZ is clinically proven to be effective in reducing blood pressure.
  • Market Growth: The global market for this combination is expected to grow, driven by increasing demand for antihypertensive treatments.
  • Regional Dynamics: The market is segmented by region, with significant growth potential in Asia and Latin America.
  • Competitive Landscape: Major manufacturers are key players, with generic versions emerging to increase market competition.
  • Regulatory Compliance: Manufacturers must adhere to regulatory standards to ensure market presence.

FAQs

What is the primary use of the combination of olmesartan medoxomil and hydrochlorothiazide?

The primary use of this combination is to treat high blood pressure (hypertension) either alone or in conjunction with other medications[4].

How does olmesartan medoxomil work?

Olmesartan medoxomil works by blocking the action of angiotensin II, which causes blood vessels to tighten, thereby relaxing the blood vessels and lowering blood pressure[4].

What are the common side effects of this combination?

Common side effects include dizziness, headache, and increased urination. Serious side effects can include kidney problems, liver disease, and allergic reactions[4].

Is this combination safe for use in elderly patients?

While this combination is generally safe for elderly patients, caution is advised due to potential age-related kidney, liver, or heart problems that may require dose adjustments[4].

Are there any contraindications for using this combination during breastfeeding?

There are no adequate studies on the use of this combination during breastfeeding, so the potential benefits must be weighed against the potential risks[4].

Sources

  1. ClinicalTrials.takeda: Long-Term Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Hypertension and Kidney Disease.
  2. QYResearch: Global Olmesartan Medoxomil Hydrochlorothiazide Tablets Market.
  3. FDA: CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW.
  4. Mayo Clinic: Olmesartan and hydrochlorothiazide (oral route).
  5. AJH: A comparative analysis of the efficacy of olmesartan medoxomil (O) and hydrochlorothiazide (HCTZ) combinations.

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