CLINICAL TRIALS PROFILE FOR OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

All Clinical Trials for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00649389 ↗	Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension	Completed	Daiichi Sankyo Inc.	Phase 3	2008-05-01	To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.
NCT00649389 ↗	Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension	Completed	Daiichi Sankyo, Inc.	Phase 3	2008-05-01	To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.
NCT00791258 ↗	A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure	Completed	Integrium	Phase 4	2008-11-01	The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.
NCT00791258 ↗	A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure	Completed	Daiichi Sankyo Inc.	Phase 4	2008-11-01	The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.

Clinical Trial Conditions for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide

Condition Name

Condition Name for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide
Intervention	Trials
Essential Hypertension	4
Healthy Subjects	2
Hypertension	2

Condition MeSH

Condition MeSH for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide
Intervention	Trials
Hypertension	6
Essential Hypertension	4

Clinical Trial Locations for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide

Trials by Country

Trials by Country for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide
Location	Trials
United States	69
Germany	2
Netherlands	2
Belgium	2
Italy	2

Trials by US State

Trials by US State for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide
Location	Trials
Pennsylvania	2
Oregon	2
Oklahoma	2
Ohio	2
North Carolina	2

Clinical Trial Progress for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide

Clinical Trial Phase

Clinical Trial Phase for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 1	2

Clinical Trial Status

Clinical Trial Status for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide
Clinical Trial Phase	Trials
Completed	8

Clinical Trial Sponsors for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide

Sponsor Name

Sponsor Name for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide
Sponsor	Trials
Daiichi Sankyo Inc.	4
Daiichi Sankyo, Inc.	4
Torrent Pharmaceuticals Limited	2

Sponsor Type

Sponsor Type for Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide
Sponsor	Trials
Industry	14

Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide: A Comprehensive Review

Introduction

Olmesartan medoxomil, amlodipine, and hydrochlorothiazide is a triple-combination antihypertensive drug, commonly known by the brand name Tribenzor. This medication is designed to treat hypertension by combining the effects of an angiotensin II receptor blocker (olmesartan medoxomil), a calcium channel blocker (amlodipine), and a thiazide diuretic (hydrochlorothiazide). Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Efficacy and Safety

The primary clinical trial supporting the approval of Tribenzor involved a randomized, double-blind, parallel-group study. This study aimed to evaluate the efficacy and safety of the triple combination therapy compared to its corresponding dual combinations. Patients were randomized to receive either the triple combination (olmesartan medoxomil 40 mg, amlodipine 10 mg, and hydrochlorothiazide 25 mg) or one of the dual combinations (olmesartan medoxomil/amlodipine 40/10 mg, olmesartan medoxomil/hydrochlorothiazide 40/25 mg, or amlodipine/hydrochlorothiazide 10/25 mg)[2][3].

The results showed that the triple combination was more efficacious in lowering seated diastolic blood pressure (SeDBP) compared to the dual combinations after 12 weeks of treatment. The study also included a 3-week stabilization/washout period and a 12-week double-blind treatment period, with a total planned duration of 57 weeks[2].

Adverse Reactions

Safety data from the clinical trials indicated that the triple combination was generally well-tolerated. The most common adverse reactions included peripheral edema, headache, fatigue, and nasopharyngitis. Dizziness was a notable adverse reaction, occurring in 5.8% to 8.9% of subjects who switched to the triple combination therapy, compared to 1.4% to 3.6% in those continuing on dual combination therapy. Discontinuations due to adverse events were higher in the triple combination group (4%) compared to the dual combination groups[1][3].

Market Analysis

Indications and Usage

Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled with dual combination therapies. This drug is not recommended for initial therapy but is effective when used alone or in combination with other antihypertensive agents to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events, such as strokes and myocardial infarctions[3][4].

Market Position

The combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide fills a significant gap in the treatment of hypertension by offering a single tablet that combines three different mechanisms of action. This convenience can improve patient compliance and simplify treatment regimens. The drug has been approved and is marketed in several countries, including the United States, where it is known as Tribenzor[2][4].

Competitive Landscape

The antihypertensive market is highly competitive, with numerous single-agent and combination therapies available. However, the unique triple-combination formulation of Tribenzor sets it apart. Other combination therapies may include dual combinations of ARBs, ACE inhibitors, calcium channel blockers, and diuretics, but Tribenzor's triple-action approach provides a distinct advantage in terms of efficacy and patient convenience[3].

Market Projections

Growth Potential

Given the prevalence of hypertension and the need for effective, convenient treatment options, the market for olmesartan medoxomil, amlodipine, and hydrochlorothiazide is expected to grow. The global hypertension treatment market is projected to increase due to factors such as an aging population, rising incidence of hypertension, and the preference for combination therapies that simplify treatment regimens and improve patient compliance.

Market Trends

The trend towards combination therapies is likely to continue, driven by the benefits of reduced pill burden and improved blood pressure control. Additionally, the increasing awareness of cardiovascular health and the importance of blood pressure management will contribute to the growth of this market segment.

Challenges and Opportunities

Despite the growth potential, there are challenges to consider, such as competition from other antihypertensive drugs and combination therapies. However, the unique formulation and proven efficacy of Tribenzor position it well to capture a significant share of the market. Opportunities also exist in expanding into new markets and developing generic versions of the drug, which could further increase its accessibility and market penetration[5].

Key Takeaways

• Efficacy: The triple combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide has been shown to be more efficacious in lowering blood pressure compared to dual combination therapies.
• Safety: The drug is generally well-tolerated, with common adverse reactions including peripheral edema, headache, and fatigue.
• Market Position: Tribenzor offers a unique triple-combination formulation that simplifies treatment regimens and improves patient compliance.
• Growth Potential: The market for this drug is expected to grow due to the increasing prevalence of hypertension and the preference for combination therapies.
• Challenges and Opportunities: While competition is a challenge, the unique formulation and potential for generic versions present significant opportunities.

FAQs

What is the primary indication for olmesartan medoxomil, amlodipine, and hydrochlorothiazide?

The primary indication is for the treatment of hypertension in patients whose blood pressure is not adequately controlled with dual combination therapies.

How does the triple combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide work?

It works by combining an angiotensin II receptor blocker (olmesartan medoxomil), a calcium channel blocker (amlodipine), and a thiazide diuretic (hydrochlorothiazide) to relax blood vessels, reduce blood volume, and lower blood pressure.

What are the common adverse reactions associated with this drug?

Common adverse reactions include peripheral edema, headache, fatigue, nasopharyngitis, and dizziness.

Is this drug suitable for initial therapy in hypertension?

No, it is not indicated for initial therapy but is recommended for patients whose blood pressure is not adequately controlled with dual combination therapies.

What is the expected market growth for this drug?

The market is expected to grow due to the increasing prevalence of hypertension and the preference for combination therapies that simplify treatment regimens and improve patient compliance.

Sources

1. FDA Label: TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) - [Access Data FDA][1]
2. FDA NDA Review: OTHER REVIEW(S) - accessdata.fda.gov - [Access Data FDA][2]
3. Drugs.com: Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide - [Drugs.com][3]
4. Mayo Clinic: Olmesartan, amlodipine, and hydrochlorothiazide (oral route) - [Mayo Clinic][4]
5. Public Assessment Report: Olmesartan medoxomil / Amlodipine / HCT Innovis - [Geneesmiddeleninformatiebank.nl][5]