CLINICAL TRIALS PROFILE FOR METOLAZONE

All Clinical Trials for metolazone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00649181 ↗	Fasting Study of Metolazone Tablets 5 mg and Zaroloxyn® Tablets 5 mg	Completed	Mylan Pharmaceuticals	Phase 1	2003-10-01	The objective of this study was to investigate the bioequivalence of Mylan metolazone 5 mg tablets to Celltech Zaroxolyn® 5 mg tablets following a single, oral 10 mg (2 x 5 mg) dose administration under fasting conditions.
NCT00649051 ↗	Fasting Study of Metolazone Tablets 2.5 mg and Zaroloxyn® Tablets 2.5 mg	Completed	Mylan Pharmaceuticals	Phase 1	2002-12-01	The objective of this study was to investigate the bioequivalence of Mylan metolazone 2.5 mg tablets to Celltech Zaroxolyn® 2.5 mg tablets following a single, oral 10 mg (4 x 2.5 mg) dose administration under fasting conditions.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.

Clinical Trial Conditions for metolazone

Condition Name

Condition Name for metolazone
Intervention	Trials
Acute Heart Failure	5
Congestive Heart Failure	4
Acute Decompensated Heart Failure	3
Healthy	3

Condition MeSH

Condition MeSH for metolazone
Intervention	Trials
Heart Failure	17
Renal Insufficiency, Chronic	2
Kidney Diseases	2
Leukemia	1

Clinical Trial Locations for metolazone

Trials by Country

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−

Trials by Country for metolazone
Location	Trials
United States	24
United Kingdom	2
Italy	2
Israel	1
Puerto Rico	1

Trials by US State

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−

Trials by US State for metolazone
Location	Trials
California	3
West Virginia	2
Virginia	2
Tennessee	2
Ohio	2

Clinical Trial Progress for metolazone

Clinical Trial Phase

Clinical Trial Phase for metolazone
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	4
Phase 2	3

Clinical Trial Status

Clinical Trial Status for metolazone
Clinical Trial Phase	Trials
Completed	6
Recruiting	5
Withdrawn	4

Clinical Trial Sponsors for metolazone

Sponsor Name

Sponsor Name for metolazone
Sponsor	Trials
Mylan Pharmaceuticals	3
Azienda Ospedaliero-Universitaria di Parma	1
NHS Greater Glasgow and Clyde	1

Sponsor Type

Sponsor Type for metolazone
Sponsor	Trials
Other	31
Industry	4
U.S. Fed	2

Metolazone: Clinical Trials, Market Analysis, and Projections

Introduction to Metolazone

Metolazone is a thiazide-like diuretic primarily used in the management of edema, heart failure, and hypertension. It was first approved in the United States in 1973 and has since become a significant player in the treatment of cardiovascular diseases[3].

Clinical Trials Update

DAPA-RESIST Trial

One of the recent and notable clinical trials involving metolazone is the DAPA-RESIST trial. This trial compared the efficacy of metolazone with dapagliflozin in patients with acute decompensated heart failure (ADHF) who were resistant to loop diuretics.

• Study Design: The trial was a multicenter, open-label, randomized, and active-comparator study.
• Patient Enrollment: 61 patients were randomized to receive either dapagliflozin 10 mg daily or metolazone 5-10 mg daily for up to three consecutive days.
• Outcomes: The trial found that dapagliflozin was not more effective than metolazone in relieving congestion. The mean decrease in weight at 96 hours was 3.0 kg with dapagliflozin and 3.6 kg with metolazone, indicating no significant difference between the two treatments[1][4].

Key Findings

• Patient Demographics: The median age of patients was 79 years, with 54% being female.
• Clinical Parameters: The median time from admission to randomization was 6 days, and the median eGFR was 41 mL/min/1.73 m².
• Treatment Adjustments: Treating physicians could adjust the doses of loop diuretics and metolazone during the study period, and some patients were switched from one treatment to the other after 72 hours[4].

Mechanism of Action

Metolazone works by indirectly decreasing the amount of water reabsorbed into the bloodstream by the kidneys, thereby reducing blood volume and increasing urine volume. This mechanism helps in lowering blood pressure and preventing excess fluid accumulation in heart failure patients[5].

Market Analysis

Current Market Trends

The metolazone market has experienced significant growth in recent years, driven by an increase in chronic diseases globally and advancements in pharmaceutical R&D.

• Market Size: The market has reached substantial value and is expected to continue growing from 2023 to 2031, with forecasts indicating robust growth rates[2][5].
• Regional Analysis: The market is analyzed across various regions, including North America, Europe, Asia-Pacific, Middle East & Africa, and South America. Each region presents unique market trends, opportunities, and competitive landscapes[5].

Market Drivers and Restraints

• Drivers: The rise in chronic diseases such as heart failure and hypertension, along with increased R&D activities in the pharmaceutical industry, are key drivers of the metolazone market.
• Restraints: Potential side effects like chest pain or bleeding associated with metolazone consumption can restrain market growth[5].

Competitive Landscape

The metolazone market is competitive, with several major players involved. The market report provides an in-depth analysis of these players, highlighting their market strategies, product offerings, and competitive positioning.

• Key Players: The report covers key players in the metolazone market, providing insights into their market share, product portfolio, and future strategies[5].

Market Projections

Forecast Period

The metolazone market is expected to witness high growth during the forecast period from 2023 to 2031.

• Revenue Growth: The market is anticipated to reach significant revenue by the end of the forecast period, driven by sustained expansion and positive market dynamics[2][5].

Regional Growth

The growth of the metolazone market varies across different regions, with each region presenting unique opportunities and challenges.

• Emerging Markets: Regions like Asia-Pacific are expected to show significant growth due to increasing healthcare expenditure and a rising prevalence of cardiovascular diseases[5].

Regulatory Status

Metolazone has been approved globally, except in China where it is still pending approval.

• Global Approval: Metolazone has successfully undergone clinical trials and met regulatory requirements for market authorization in most countries[3].

Conclusion

Metolazone remains a crucial drug in the management of heart failure and hypertension, with ongoing clinical trials and market analyses highlighting its efficacy and market potential.

Key Takeaways

• Clinical Efficacy: Metolazone is as effective as dapagliflozin in relieving congestion in patients with ADHF resistant to loop diuretics.
• Market Growth: The metolazone market is expected to grow significantly from 2023 to 2031, driven by increasing chronic diseases and R&D advancements.
• Regulatory Status: Metolazone is approved globally except in China, where it awaits regulatory clearance.
• Mechanism of Action: Metolazone works by reducing water reabsorption in the kidneys, thereby lowering blood pressure and preventing fluid accumulation.

FAQs

What is the primary use of metolazone?

Metolazone is primarily used to treat edema, heart failure, and hypertension by reducing fluid accumulation and lowering blood pressure.

How does metolazone compare to dapagliflozin in heart failure treatment?

In the DAPA-RESIST trial, metolazone was found to be as effective as dapagliflozin in relieving congestion in patients with acute decompensated heart failure resistant to loop diuretics.

What are the key drivers of the metolazone market?

The rise in chronic diseases and advancements in pharmaceutical R&D are key drivers of the metolazone market.

Is metolazone approved globally?

Metolazone is approved globally except in China, where it is still pending regulatory approval.

What are the potential side effects of metolazone?

Potential side effects of metolazone include chest pain and bleeding, which can restrain market growth.

Sources

1. Dapagliflozin vs. metolazone in heart failure resistant to loop diuretics - European Heart Journal[1]
2. Global Metolazone Sales Market Size, Scope And Forecast Report - Market Research Intellect[2]
3. Deep Scientific Insights on Metolazone's R&D Progress, Mechanism of Action - Synapse Patsnap[3]
4. Dapagliflozin vs. Metolazone in Heart Failure Resistant to Loop Diuretics - American College of Cardiology[4]
5. Metolazone Market - Regional And Competitive Landscape - OpenPR[5]