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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR HYZAAR


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All Clinical Trials for Hyzaar

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00234858 ↗ Tarka vs. Hyzaar in Patients With Metabolic Syndrome (STAR) Completed Abbott Phase 4 2004-03-01 The primary objective of this study is to determine whether impaired glucose tolerance is improved to a greater degree by Tarka than Hyzaar in subjects with metabolic syndrome
NCT00274638 ↗ PROBE Parallel 6-week Treatment Comparing Telmisartan/Hydrochlorothiazide (HCT) (40/12.5 or 80/12.5) With Losartan/HCT (50/12.5) Using Ambulatory Blood Pressure Monitoring (ABPM) Completed Boehringer Ingelheim Phase 4 2002-07-01 To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate hypertensives.
NCT00354991 ↗ Hyzaar Asia HEAALTH (0954A-950) Completed Merck Sharp & Dohme Corp. Phase 3 2006-06-01 The objective of the study is to estimate the percentage of patients who reach blood pressure goal after 8 weeks of treatment with losartan/HCTZ combination.
NCT00398541 ↗ Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients (0954A-322) Completed Merck Sharp & Dohme Corp. Phase 3 2005-03-01 Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in comparison with Natrilix(TM).
NCT00400218 ↗ Evaluate the Safety and Anti-Hypertensive Efficacy of Hyzaar(R) In Patients With Mild To Moderate Essential Hypertension (0954A-323) Completed Merck Sharp & Dohme Corp. Phase 3 2005-09-01 Evaluate the safety and anti-hypertensive efficacy of hyzaar(R) in patients with mild to moderate essential hypertension.
NCT00480805 ↗ HYZAAR vs. Ramipril for Diabetes (0954A-245)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2001-08-08 A study to test the safety and efficacy of HYZAAR as compared to Ramipril in patients with type 2 diabetes mellitus (high blood sugar) and hypertension (high blood pressure).
NCT01149473 ↗ Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions Completed Teva Pharmaceuticals USA Phase 1 2004-03-01 The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) with that of Hyzaar® 100/25 mg tablets (Merck) in healthy, adult, non-smoking subjects under non-fasting conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hyzaar

Condition Name

Condition Name for Hyzaar
Intervention Trials
Hypertension 9
Healthy 4
Healthy Subjects 1
Metabolic Syndrome 1
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Condition MeSH

Condition MeSH for Hyzaar
Intervention Trials
Hypertension 9
Malnutrition 1
Diabetes Mellitus, Type 2 1
Diabetes Mellitus 1
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Clinical Trial Locations for Hyzaar

Trials by Country

Trials by Country for Hyzaar
Location Trials
United States 29
Brazil 2
Jordan 1
India 1
France 1
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Trials by US State

Trials by US State for Hyzaar
Location Trials
North Dakota 2
Georgia 2
Arkansas 1
Alabama 1
Wisconsin 1
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Clinical Trial Progress for Hyzaar

Clinical Trial Phase

Clinical Trial Phase for Hyzaar
Clinical Trial Phase Trials
Phase 4 4
Phase 3 6
Phase 1 6
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Clinical Trial Status

Clinical Trial Status for Hyzaar
Clinical Trial Phase Trials
Completed 12
Unknown status 2
Recruiting 1
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Clinical Trial Sponsors for Hyzaar

Sponsor Name

Sponsor Name for Hyzaar
Sponsor Trials
Merck Sharp & Dohme Corp. 4
Teva Pharmaceuticals USA 2
Torrent Pharmaceuticals Limited 2
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Sponsor Type

Sponsor Type for Hyzaar
Sponsor Trials
Industry 14
Other 2
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HYZAAR: Clinical Trials, Market Analysis, and Projections

Introduction

HYZAAR, a fixed-dose combination of losartan and hydrochlorothiazide, is a widely used medication for the treatment of hypertension and other cardiovascular conditions. This article will delve into the clinical trials associated with HYZAAR, analyze its current market standing, and provide projections for its future growth.

Clinical Trials Overview

Efficacy and Safety

Clinical trials have been instrumental in establishing the efficacy and safety profile of HYZAAR. In controlled clinical studies, HYZAAR has been shown to effectively reduce blood pressure in patients with hypertension. The usual starting dose is 50/12.5 mg (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily, which can be increased to a maximum of 100/25 mg as needed[3].

Adverse Reactions

Adverse reactions reported in clinical trials include back pain, dizziness, and upper respiratory infections, occurring at a higher rate than in the placebo group. More severe adverse reactions such as anemia, aplastic anemia, and electrolyte imbalance have also been reported, although these are less common[1].

Specific Studies

  • The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial involved patients with type 2 diabetes and renal impairment. It found that combining losartan with lisinopril did not provide additional benefits over monotherapy but increased the risk of hyperkalemia and acute kidney injury[1][3].

  • A study comparing losartan to ACE inhibitors and hydrochlorothiazide showed that losartan had a lower incidence of cough, a common side effect of ACE inhibitors[1][3].

COVID-19 Trials

In a multicenter phase II randomized clinical trial, losartan was tested for its efficacy in treating mild symptomatic COVID-19. The trial found that losartan did not reduce hospitalizations and had a similar adverse event profile to the placebo group. The trial was terminated early due to a lower than expected hospitalization rate and the low likelihood of a clinically important treatment effect[4].

Market Analysis

Current Market Size

The global losartan market, which includes HYZAAR, stood at US$ 1.5 billion in 2023. This market is driven by the increasing prevalence of hypertension worldwide, attributed to aging populations, sedentary lifestyles, and dietary factors[5].

Regional Market Share

North America holds the largest share of the losartan market, supported by robust healthcare infrastructure and access to medical resources. The Asia Pacific region also has a substantial share, fueled by increasing adoption in countries like Singapore and Malaysia, and awareness campaigns in populous nations such as India and China[5].

Growth Drivers

The market expansion is propelled by several key factors:

  • Increasing Prevalence of Hypertension: The rising incidence of hypertension due to aging populations and lifestyle factors is a significant driver.
  • Prefrail Geriatric Population: Losartan shows promise in improving frailty measures among prefrail older adults, reducing the risk of adverse health outcomes[5].
  • Cardiovascular Benefits: Losartan's ability to mitigate angiotensin II-induced cardiac remodeling and reduce the risk of stroke by broadening and relaxing blood vessels further drives its demand[5].

Market Projections

Future Growth

The global losartan market is projected to expand to US$ 2.3 billion by 2034, growing at a CAGR of 4% between 2024 and 2034. This growth is anticipated due to the increasing demand for effective hypertension management and the expanding geriatric population[5].

Segmentation

The market is segmented by dosage form (tablets, powder, suspension), application (hypertension, stroke, diabetic nephropathy), and distribution channel (contract manufacturing, in-house manufacturing). Regional segmentation includes North America, Europe, Asia Pacific, Middle East & Africa, and Latin America[5].

Regulatory and Safety Concerns

Recall Notices

In 2018, Sandoz voluntarily recalled one lot of HYZAAR due to the presence of an impurity, N-nitrosodimethylamine, which is classified as a probable human carcinogen. This recall was part of a broader action by the FDA to address similar impurities in various blood pressure medications[2].

Monitoring and Contraindications

Patients on HYZAAR need to be closely monitored for blood pressure, renal function, and electrolytes, especially when combined with other agents that affect the renin-angiotensin system (RAS). Co-administration with aliskiren is contraindicated in patients with diabetes or renal impairment[1][3].

Key Takeaways

  • Clinical Efficacy: HYZAAR is effective in reducing blood pressure and is used for treating hypertension and other cardiovascular conditions.
  • Adverse Reactions: Common adverse reactions include back pain, dizziness, and upper respiratory infections, with more severe reactions such as anemia and electrolyte imbalance reported less frequently.
  • Market Growth: The global losartan market is projected to grow to US$ 2.3 billion by 2034, driven by increasing hypertension prevalence and the expanding geriatric population.
  • Regulatory Concerns: Patients and healthcare providers must be aware of potential recalls and the need for close monitoring of patients on HYZAAR.

FAQs

What is HYZAAR used for?

HYZAAR is used to treat hypertension and other cardiovascular conditions by combining losartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a diuretic.

What are the common adverse reactions associated with HYZAAR?

Common adverse reactions include back pain, dizziness, and upper respiratory infections. More severe reactions such as anemia, aplastic anemia, and electrolyte imbalance can also occur.

Why was HYZAAR recalled in 2018?

HYZAAR was recalled in 2018 due to the presence of an impurity, N-nitrosodimethylamine, which is classified as a probable human carcinogen.

What is the projected growth of the global losartan market?

The global losartan market is projected to grow to US$ 2.3 billion by 2034, expanding at a CAGR of 4% between 2024 and 2034.

Are there any contraindications for using HYZAAR?

Yes, HYZAAR should not be co-administered with aliskiren in patients with diabetes or renal impairment (GFR <60 mL/min).

What are the key drivers of the losartan market growth?

The key drivers include the increasing prevalence of hypertension, the expanding geriatric population, and losartan's efficacy in managing hypertension and reducing cardiovascular risks.

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