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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR COZAAR


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All Clinical Trials for Cozaar

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00168857 ↗ A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Ove Completed Boehringer Ingelheim Phase 4 2003-07-01 A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg, another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR) 100 mg in reducing the level of urinary protein (indicative of improved kidney function).
NCT00223717 ↗ Treatment of Supine Hypertension in Autonomic Failure Completed Vanderbilt University Phase 1 2001-01-01 Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗ Treatment of Supine Hypertension in Autonomic Failure Completed Vanderbilt University Medical Center Phase 1 2001-01-01 Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00275639 ↗ The Effects of Angiotensin II Receptor Blockade on Kidney Function and Scarring After Liver Transplant Completed Mayo Clinic Phase 4 2004-12-01 This research study is being done to study the effects, both good and bad, of calcineurin inhibitors and the drug Cozaar (losartan), on kidney function and kidney scarring following a liver transplant.
NCT00340678 ↗ Renoprotection in Early Diabetic Nephropathy in Pima Indians Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 1995-08-01 This investigation is a randomized, double-blinded, placebo-controlled clinical trial in adult diabetic Pima Indians with normal urinary albumin excretion (albumin-to-creatinine ration less than 30 mg/g) or microalbuminuria (albumin-to-creatinine ration = 30-299 mg/g) to test the hypothesis that blockade of the renin-angiotensin system with the angiotensin receptor blocker (ARB) losartan can prevent or further attenuate the development and progression of early diabetic nephropathy in subjects with type 2 diabetes mellitus who are receiving standard diabetes care. One hundred seventy subjects were recruited for the study, all of whom had type 2 diabetes for at least 5 years, serum creatinine concentrations less than 1.4 mg/dl, and no evidence of non-diabetic renal diseases. Ninety-two of the subjects had normal urinary albumin excretion at baseline and other 78 had microalbuminuria. Subjects in each albumin excretion group were randomized to treatment with either the angiotensin II receptor antagonist, losartan, or placebo. Measurements of glomerular filtration rate (GFR), renal plasma flow (RPF) and fractional clearances of albumin and IgG will be made initially, at one month, and at 12-month intervals from baseline thereafter. A kidney biopsy was performed after six years in 111 subjects. Morphometric analysis of renal biopsies was used to determine differences in glomerular structure between treatment groups.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cozaar

Condition Name

Condition Name for Cozaar
Intervention Trials
Hypertension 27
Healthy 6
High Blood Pressure 2
Kidney Disease 2
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Condition MeSH

Condition MeSH for Cozaar
Intervention Trials
Hypertension 27
Kidney Diseases 10
Fibrosis 5
Diabetic Nephropathies 4
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Clinical Trial Locations for Cozaar

Trials by Country

Trials by Country for Cozaar
Location Trials
United States 114
China 29
Canada 11
Korea, Republic of 6
Argentina 4
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Trials by US State

Trials by US State for Cozaar
Location Trials
California 9
Florida 9
New York 7
Massachusetts 7
Georgia 7
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Clinical Trial Progress for Cozaar

Clinical Trial Phase

Clinical Trial Phase for Cozaar
Clinical Trial Phase Trials
Phase 4 24
Phase 3 11
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Cozaar
Clinical Trial Phase Trials
Completed 54
Terminated 8
Recruiting 7
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Clinical Trial Sponsors for Cozaar

Sponsor Name

Sponsor Name for Cozaar
Sponsor Trials
Merck Sharp & Dohme Corp. 10
Boehringer Ingelheim 3
National Heart, Lung, and Blood Institute (NHLBI) 3
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Sponsor Type

Sponsor Type for Cozaar
Sponsor Trials
Other 90
Industry 38
NIH 11
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COZAAR (Losartan): Clinical Trials Update, Market Analysis, and Projections

Introduction

COZAAR, known generically as losartan, is an angiotensin II receptor antagonist (ARB) widely used to treat high blood pressure and protect the kidneys from damage due to diabetes. Here, we will delve into recent clinical trials, market analysis, and future projections for this medication.

Clinical Trials Update

Losartan in Acute COVID-19

A recent clinical trial, the ARBs CORONA II study, investigated the use of losartan in patients hospitalized for acute COVID-19. This prospective, open-label, randomized trial was conducted in 29 hospitals in Canada and France between October 2020 and March 2022. The trial aimed to determine if losartan could reduce 28-day mortality and improve outcomes in patients not previously on ARBs or ACE inhibitors.

However, the trial was stopped early due to significant safety concerns. Patients receiving losartan experienced higher rates of serious adverse events (SAEs) and hypotension compared to those receiving usual care. The study concluded that losartan should not be used for the treatment of acute COVID-19 due to these safety concerns[1].

Losartan in Marfan Syndrome

The COMPARE trial examined the long-term clinical outcomes of losartan in patients with Marfan syndrome. This study showed a small but significant beneficial effect of 3-year losartan treatment on aortic root dilatation rate. Patients treated with losartan had fewer adverse events, including deaths, aortic dissections, and elective aortic root replacements, compared to the control group. This suggests a clinical benefit of combined losartan and β-blocker treatment in patients with Marfan syndrome[3].

Losartan in Pancreatic Cancer

Research at Massachusetts General Hospital has explored the potential of losartan in enhancing the efficacy of cancer treatments. The study found that losartan may potentiate the benefits of chemotherapy and radiation therapy (FFX+CRT) by reducing tumor invasion and immunosuppression in patients with locally advanced pancreatic cancer. Ongoing clinical trials are evaluating the effectiveness of adding losartan to various cytotoxic treatment regimens or immunotherapy for pancreatic cancer[4].

Market Analysis

Global Market Size and Growth

The global losartan market is projected to be substantial, with a market size estimated at USD 1625.5 million in 2024. This market is expected to grow at a compound annual growth rate (CAGR) of 4.50% from 2024 to 2031, reaching USD 2212.1 million by 2031. North America currently dominates the market, holding over 40% of the global revenue, followed by Europe and the Asia-Pacific region[2].

Regional Market Breakdown

  • North America: With a market size of USD 650.2 million in 2024, this region is expected to grow at a CAGR of 2.7% from 2024 to 2031.
  • Europe: Holding around 30% of the global revenue, the European market is estimated at USD 487.65 million in 2024 and is expected to grow at a CAGR of 3.0% from 2024 to 2031.
  • Asia-Pacific: This region holds around 23% of the global revenue, with a market size of USD 373.87 million in 2024, and is expected to grow at a CAGR of 6.5% from 2024 to 2031.
  • Latin America and Middle East & Africa: These regions hold smaller market shares but are also expected to see growth, with CAGRs of 3.9% and 4.2%, respectively[2].

Losartan Potassium API Market

The global Losartan Potassium API market is another significant segment, estimated at USD 1652.2 million in 2024. This market is projected to grow at a CAGR of 5.50% from 2024 to 2031, reaching USD 2403.42 million by 2031. The Asia-Pacific region is expected to witness the highest growth rate in this segment, with a CAGR of 7.5% from 2024 to 2031[5].

Projections and Future Outlook

Market Expansion

The increasing prevalence of hypertension and cardiovascular diseases, particularly in aging populations, is driving the demand for losartan. The expansion of global healthcare infrastructure and the growing awareness of cardiovascular health are expected to further boost the market.

Emerging Applications

The potential use of losartan in cancer treatment, as indicated by the research on pancreatic cancer, could open new avenues for the drug. Ongoing and future clinical trials will be crucial in determining the efficacy and safety of losartan in these new applications.

Competitive Landscape

The losartan market is competitive, with multiple manufacturers and generic versions available. The market is expected to remain competitive, with new entrants and ongoing research potentially altering the market dynamics.

Key Takeaways

  • Clinical Trials: Recent trials have highlighted safety concerns with losartan in acute COVID-19 but shown benefits in Marfan syndrome and potential in pancreatic cancer.
  • Market Size: The global losartan market is substantial, with a projected size of USD 1625.5 million in 2024, growing at a CAGR of 4.50% to 2031.
  • Regional Growth: North America, Europe, and the Asia-Pacific region are key markets, with the latter showing the highest growth rate.
  • API Market: The Losartan Potassium API market is also growing, driven by demand in the pharmaceutical industry.
  • Future Outlook: Emerging applications in cancer treatment and growing healthcare infrastructure are expected to drive market expansion.

FAQs

What were the findings of the ARBs CORONA II trial regarding losartan in acute COVID-19?

The ARBs CORONA II trial found that losartan increased the risk of serious adverse events and hypotension in patients hospitalized for acute COVID-19, leading to the trial being stopped early due to safety concerns[1].

How does losartan benefit patients with Marfan syndrome?

Losartan has been shown to reduce the rate of aortic root dilatation and decrease the number of adverse events such as deaths and aortic dissections in patients with Marfan syndrome when used in combination with β-blockers[3].

What is the potential role of losartan in pancreatic cancer treatment?

Research suggests that losartan may enhance the efficacy of chemotherapy and radiation therapy by reducing tumor invasion and immunosuppression in patients with locally advanced pancreatic cancer[4].

What is the projected growth rate of the global losartan market from 2024 to 2031?

The global losartan market is expected to grow at a compound annual growth rate (CAGR) of 4.50% from 2024 to 2031[2].

Which region is expected to have the highest growth rate in the Losartan Potassium API market?

The Asia-Pacific region is expected to have the highest growth rate in the Losartan Potassium API market, with a CAGR of 7.5% from 2024 to 2031[5].

Sources

  1. Effects of Losartan on Patients Hospitalized for Acute COVID-19 - Clinical Infectious Diseases, 2024.
  2. Global Losartan Market Report - Cognitive Market Research, 2024.
  3. Long-term clinical outcomes of losartan in patients with Marfan syndrome - European Heart Journal, 2020.
  4. New insights into how blood pressure drug may benefit patients with locally advanced pancreatic cancer - Massachusetts General Hospital, 2023.
  5. Global Losartan Potassium API Market Report - Cognitive Market Research, 2024.

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