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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR OLMESARTAN MEDOXOMIL


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All Clinical Trials for Olmesartan Medoxomil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00134160 ↗ OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study Completed Japan Heart Foundation Phase 4 2005-08-01 The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone.
NCT00134160 ↗ OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study Completed OSCAR Study Phase 4 2005-08-01 The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone.
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
NCT00141453 ↗ ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial Completed Daiichi Sankyo Co., Ltd. Phase 3 2003-04-01 The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.
NCT00151775 ↗ Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure Completed Daiichi Sankyo Inc. Phase 2/Phase 3 2005-05-01 This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16 with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks participants can continue to take olmesartan medoxomil (OM) for up to an additional 46 weeks.
NCT00151775 ↗ Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure Completed Daiichi Sankyo, Inc. Phase 2/Phase 3 2005-05-01 This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16 with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks participants can continue to take olmesartan medoxomil (OM) for up to an additional 46 weeks.
NCT00151814 ↗ Olmesartan Pediatric Pharmacokinetic (PK) Study Completed Daiichi Sankyo Inc. Phase 1 2005-09-01 Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Olmesartan Medoxomil

Condition Name

Condition Name for Olmesartan Medoxomil
Intervention Trials
Hypertension 31
Essential Hypertension 23
Healthy 6
Healthy Subjects 4
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Condition MeSH

Condition MeSH for Olmesartan Medoxomil
Intervention Trials
Hypertension 54
Essential Hypertension 27
Kidney Diseases 5
Diabetes Mellitus, Type 2 4
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Clinical Trial Locations for Olmesartan Medoxomil

Trials by Country

Trials by Country for Olmesartan Medoxomil
Location Trials
United States 367
Germany 29
Netherlands 13
Mexico 11
Poland 9
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Trials by US State

Trials by US State for Olmesartan Medoxomil
Location Trials
California 17
Florida 16
Texas 15
Ohio 15
North Carolina 15
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Clinical Trial Progress for Olmesartan Medoxomil

Clinical Trial Phase

Clinical Trial Phase for Olmesartan Medoxomil
Clinical Trial Phase Trials
Phase 4 24
Phase 3 37
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Olmesartan Medoxomil
Clinical Trial Phase Trials
Completed 67
Unknown status 7
Terminated 3
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Clinical Trial Sponsors for Olmesartan Medoxomil

Sponsor Name

Sponsor Name for Olmesartan Medoxomil
Sponsor Trials
Daiichi Sankyo Inc. 23
Daiichi Sankyo, Inc. 23
Daiichi Sankyo Europe, GmbH 9
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Sponsor Type

Sponsor Type for Olmesartan Medoxomil
Sponsor Trials
Industry 111
Other 16
NIH 1
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Olmesartan Medoxomil: Clinical Trials Update, Market Analysis, and Projections

Introduction to Olmesartan Medoxomil

Olmesartan medoxomil, a prodrug that converts to olmesartan in the gastrointestinal tract, is an angiotensin II receptor blocker (ARB) used to treat hypertension, kidney failure, and certain cases of heart attacks. It works by relaxing blood vessels, allowing blood to flow more easily.

Current Clinical Trials

Ongoing and Upcoming Trials

Several clinical trials are currently underway or planned for olmesartan medoxomil:

  • Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT: This Phase 3 trial, sponsored by EMS, is comparing the efficacy and safety of olmesartan medoxomil combined with chlorthalidone against Benicar HCT. The trial is expected to complete by November 2026, with primary completion anticipated by June 2026[1].

  • Bioequivalence Study of Olmesartan Medoxomil/Hydrochlorothiazide: A Phase 1 trial is ongoing to assess the bioequivalence of two different formulations of olmesartan medoxomil/hydrochlorothiazide after a single oral dose under fasting conditions. This trial is sponsored by Pharmtechnology LLC and is currently recruiting participants[1].

  • New Phase 1 Trials: Additional Phase 1 trials have been initiated to compare different formulations and dosages of olmesartan medoxomil, with some trials expected to complete by June 2025[1].

Recent Trial Outcomes

  • ROADMAP Trial: The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial examined the effects of olmesartan in patients with diabetes. While olmesartan delayed the onset of microalbuminuria, it had no beneficial effect on kidney function and was associated with an increased risk of cardiovascular deaths and strokes in diabetic patients[4].

  • Efficacy in Reducing Blood Pressure: Studies have shown that olmesartan medoxomil is effective in reducing systolic blood pressure (SBP) and pulse pressure (PP) in hypertensive patients. A meta-analysis of seven randomized trials demonstrated mean reductions in SBP of 15.1 and 17.6 mm Hg for 20 mg and 40 mg doses, respectively[5].

Market Analysis

Market Size and Growth

The global olmesartan medoxomil market is expected to witness significant growth driven by the rising prevalence of cardiovascular disorders such as hypertension, stroke, and cardiac arrest. The market is also influenced by the increasing geriatric population worldwide.

  • Global Market Forecast: The olmesartan medoxomil market is predicted to record a substantial Compound Annual Growth Rate (CAGR) from 2023 to 2031. The market size is expected to increase from US$ XX million in 2023 to US$ XX million by 2031[3].

  • Regional Breakdown: The market is segmented by region, with detailed forecasts provided for North America, Europe, APAC, MEA, and South & Central America. The report includes sales and revenue data by region, highlighting growth rates and market shares[2][3].

Market Segmentation

The olmesartan medoxomil market is segmented based on product and application:

  • Product Segmentation: The market is segmented into different dosages, such as 20 mg and 40 mg tablets[3].

  • Application Segmentation: The primary applications include hypertension, kidney failure, and heart attacks. The report provides detailed insights into each application segment, including market size, growth rates, and revenue forecasts[3].

Key Drivers and Restraints

  • Drivers: The increasing incidence of cardiovascular diseases, an aging population, and the effectiveness of olmesartan medoxomil in managing hypertension are key drivers of the market[3].

  • Restraints: Potential side effects, such as dizziness, muscle weakness, and allergic reactions, along with the findings from the ROADMAP trial indicating increased cardiovascular risks in diabetic patients, are expected to restrain market growth[3][4].

Competitive Landscape

The olmesartan medoxomil market is competitive, with several major manufacturers involved:

  • Original and Generic Manufacturers: Companies like Daiichi Sankyo, the original manufacturer, and various generic drug manufacturers are active in the market. The report provides profiles of key companies, including their market share, product offerings, and strategic initiatives[2][3].

  • Market Share: The competitive landscape includes an analysis of the market share held by each major player, both globally and regionally[2][3].

PEST and SWOT Analysis

The market analysis includes a comprehensive PEST (Political, Economic, Social, and Technological) analysis and SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis to provide a holistic view of the market environment.

  • PEST Analysis: This analysis evaluates the impact of political, economic, social, and technological factors on the olmesartan medoxomil market across different regions[3].

  • SWOT Analysis: The report identifies the strengths, weaknesses, opportunities, and threats facing the market, helping stakeholders make informed decisions[3].

Future Trends and Opportunities

The olmesartan medoxomil market is expected to see several trends and opportunities in the forecast period:

  • Increasing Demand: The growing demand for antihypertensive medications due to the rising prevalence of hypertension and other cardiovascular diseases will drive market growth[3].

  • Advancements in Formulations: Research into new formulations, such as nano-scale particles to enhance bioavailability, is expected to improve the efficacy and safety profile of olmesartan medoxomil[1].

  • Generic Market Expansion: The expiration of patents for olmesartan medoxomil has led to an increase in generic versions, which will continue to shape the market landscape[2].

Key Takeaways

  • Clinical Trials: Ongoing and planned trials are focusing on the efficacy and safety of olmesartan medoxomil in various patient populations.
  • Market Growth: The global market is expected to grow significantly due to increasing demand for antihypertensive medications.
  • Segmentation: The market is segmented by product and application, with detailed forecasts provided for each segment.
  • Competitive Landscape: The market is competitive, with both original and generic manufacturers playing key roles.
  • PEST and SWOT Analysis: These analyses provide insights into the market environment and potential opportunities and threats.

FAQs

What is olmesartan medoxomil used for?

Olmesartan medoxomil is used to treat hypertension, kidney failure, and certain cases of heart attacks by relaxing blood vessels and improving blood flow.

What are the potential side effects of olmesartan medoxomil?

Potential side effects include dizziness, muscle weakness, shortening of breathing, and allergic reactions. There is also a concern about increased cardiovascular risks in diabetic patients taking high doses.

What is the current status of clinical trials for olmesartan medoxomil?

Several clinical trials are ongoing or planned, including a Phase 3 trial comparing olmesartan medoxomil with chlorthalidone versus Benicar HCT, and Phase 1 trials assessing bioequivalence and new formulations.

How is the olmesartan medoxomil market segmented?

The market is segmented by product (20 mg and 40 mg tablets) and application (hypertension, kidney failure, and heart attacks).

What are the key drivers of the olmesartan medoxomil market?

Key drivers include the rising prevalence of cardiovascular diseases, an aging population, and the effectiveness of olmesartan medoxomil in managing hypertension.

Sources

  1. LARVOL Sigma: Benicar (olmesartan medoxomil) News.
  2. QYResearch: Global Olmesartan Medoxomil Hydrochlorothiazide Tablets Market.
  3. The Insight Partners: Olmesartan Medoxomil Market SWOT Analysis by 2031.
  4. FDA: FDA review of cardiovascular risks for diabetics taking hypertension drug.
  5. American Journal of Hypertension: Effects of olmesartan medoxomil on systolic blood pressure and pulse pressure.

More… ↓

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