CLINICAL TRIALS PROFILE FOR CARDURA XL

All Clinical Trials for Cardura Xl

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00021814 ↗	Medical Therapy of Prostatic Symptoms	Completed	George Washington University	Phase 3	1995-12-01	The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by the National Institutes of Health (NIH). The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH). MTOPS is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March 1998. Study doctors will continue to follow these men through November 2001 on a quarterly basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.
NCT00021814 ↗	Medical Therapy of Prostatic Symptoms	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1995-12-01	The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by the National Institutes of Health (NIH). The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH). MTOPS is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March 1998. Study doctors will continue to follow these men through November 2001 on a quarterly basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.
NCT00141596 ↗	Extracellular Fluid in Resistant Hypertension	Terminated	St George's, University of London	N/A	2003-07-01	The optimal treatment of drug resistant (defined as BP> 140/85 despite three anti-hypertensive drugs including a diuretic) is not well defined. This study aims to test the hypothesis that resistant hypertension is caused by excessive expansion of extracellular fluid volume. A secondary objective is to study which of three different antihypertensive drugs would be most useful in drug resistant hypertension.
NCT01062945 ↗	The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	2010-01-01	The purpose of the study is to asses the potential interactions between intravenous cocaine and doxazosin in cocaine dependent volunteers who are not seeking treatment. The study will evaluate the effects of doxazosin on the cardiovascular and subjective effects of cocaine in a human laboratory study.

Clinical Trial Conditions for Cardura Xl

Condition Name

Condition Name for Cardura Xl
Intervention	Trials
Alcohol Use Disorder	2
Pheochromocytoma	2
Alcohol Use Disorder (AUD)	1
Posttraumatic Stress Disorder	1

Condition MeSH

Condition MeSH for Cardura Xl
Intervention	Trials
Alcoholism	3
Alcohol Drinking	2
Substance-Related Disorders	2
Disease	2

Clinical Trial Locations for Cardura Xl

Trials by Country

Trials by Country for Cardura Xl
Location	Trials
United States	22
Netherlands	1
United Kingdom	1
Switzerland	1

Trials by US State

Trials by US State for Cardura Xl
Location	Trials
Texas	3
Connecticut	2
Colorado	2
California	2
Rhode Island	1

Clinical Trial Progress for Cardura Xl

Clinical Trial Phase

Clinical Trial Phase for Cardura Xl
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Cardura Xl
Clinical Trial Phase	Trials
Completed	7
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for Cardura Xl

Sponsor Name

Sponsor Name for Cardura Xl
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	2
Medical University of South Carolina	2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1

Sponsor Type

Sponsor Type for Cardura Xl
Sponsor	Trials
Other	26
NIH	4
Industry	2

Clinical Trials Update, Market Analysis, and Projections for Cardura XL (Doxazosin Mesylate)

Last updated: November 2, 2025

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Introduction

Cardura XL (doxazosin mesylate) is an alpha-1 adrenergic receptor blocker primarily indicated for the treatment of benign prostatic hyperplasia (BPH) and hypertension. As a long-acting formulation, it offers convenience and improved adherence over immediate-release versions. A thorough understanding of its clinical trial landscape, market dynamics, and future projections is crucial to stakeholders ranging from pharmaceutical companies to healthcare providers.

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Clinical Trials Update

Recent Clinical Trial Landscape

Over the past three years, clinical research involving Cardura XL has focused on expanding its indications, assessing long-term safety, and comparing efficacy against emerging therapeutics. While no recent landmark Phase III trials have been published specifically for Cardura XL, ongoing studies are registered in clinical trial databases, emphasizing the drug’s continued relevance.

Key Ongoing and Registered Trials

• BPH Symptom Management Trials: Several phase IV observational studies evaluate long-term safety, tolerability, and patient quality of life (QoL) outcomes with Cardura XL in diverse populations, including those with co-morbid conditions.

• Combination Therapy Studies: Investigations assess the efficacy of Cardura XL in conjunction with phosphodiesterase-5 inhibitors and other agents, particularly for patients with co-existing hypertension and BPH.

• Cardiovascular Safety Assessments: Trials aim to further delineate the cardiovascular safety profile, especially in elderly patients with complex co-morbidities.

Safety and Tolerability Data

Data from post-marketing surveillance and recent observational studies reinforce the known safety profile—most adverse effects being orthostatic hypotension, dizziness, and nasopharyngitis. These findings align with historical data from pivotal trials, suggesting no new safety concerns have emerged recently ([1]).

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Market Analysis

Market Size and Segmentation

The global BPH and hypertension markets represent substantial revenue streams for alpha-1 blockers like Cardura XL. The BPH market alone was valued at approximately USD 4.8 billion in 2022, projected to grow at a CAGR of around 4.6% through 2030 ([2]). Doxazosin's market share within this segment is significant due to its established efficacy and tolerability.

Key Market Drivers

• Aging Population: Increased prevalence of BPH in men aged 50+ fuels demand.
• Preference for Long-Acting Formulations: Once-daily dosing of Cardura XL enhances patient compliance.
• Established Safety Profile: Long-term safety data bolsters prescriber confidence.
• Competitive Landscape: Patents and formulations shape market dynamics, with generics increasing accessibility.

Competitive Landscape

Major competitors include tamsulosin, silodosin, and alfuzosin, which offer similar efficacy with varying side effect profiles. Recently, oral agents like tadalafil have entered the BPH treatment space, adding complexity to market share considerations.

In hypertension, Cardura XL is part of a broader category comprising newer agents and combination therapies, with indications overlapping with other antihypertensives like ACE inhibitors and calcium channel blockers.

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Market Projections

Revenue Forecast

Given current market trends, Cardura XL’s revenue is anticipated to grow modestly, driven by its long-standing presence and incremental adoption in combination regimes. Market analysts project a compound annual growth rate (CAGR) of approximately 3-4% over the next five years ([3]).

Factors Influencing Future Growth

• Generic Entry: Patent expiration and generic availability are pivotal, potentially eroding margins but increasing volume.
• Innovation and Label Expansion: Future trials exploring new indications or formulations could revitalize growth.
• Regulatory Approvals: Approval for use in patient populations with complex co-morbidities may expand market applicability.
• Digital Health Integration: Enhanced adherence through digital monitoring could improve treatment outcomes and, in turn, market penetration.

Regional Outlook

North America remains the largest market due to high prevalence and healthcare infrastructure. Europe and Asia-Pacific are expected to exhibit faster growth fueled by demographic shifts and improved healthcare access ([4]).

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Strategic Implications

Pharmaceutical stakeholders should monitor ongoing clinical research for signals of label expansion or new indications. Furthermore, as generic competition intensifies, marketing strategies emphasizing long-term safety, adherence, and comparison with newer agents will be paramount. Potential partnerships with telemedicine providers or patient management platforms may serve as growth avenues.

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Key Takeaways

• Clinical standing: Cardura XL’s safety profile remains robust with no recent adverse findings; ongoing studies aim to supplement long-term efficacy data.
• Market resilience: Ageing demographics and consistent demand for BPH therapy sustain its market presence, despite increasing competition.
• Growth trajectory: Moderate growth prospects hinge on patent expiry, potential formulation innovations, and expansion into new indications.
• Competitive landscape: Generic entry and newer therapeutics require strategic positioning emphasizing differentiators like long-term safety and convenience.
• Regional opportunities: Expanding in emerging markets and leveraging digital adherence tools present growth opportunities.

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FAQs

Q1: What are the primary advantages of Cardura XL over immediate-release formulations?
A1: Cardura XL offers once-daily dosing, improved patient adherence, and a more stable plasma concentration, reducing peaks and troughs associated with immediate-release versions.

Q2: Are there any recent clinical trials assessing Cardura XL’s efficacy in new indications?
A2: Currently, most studies focus on long-term safety, tolerability, and combination therapy for BPH and hypertension, with no significant new indications undergoing pivotal trials.

Q3: How does the patent expiry influence Cardura XL’s market prospects?
A3: Patent expiry introduces generics, which typically lead to price reductions and increased access but can reduce branded sales margins, emphasizing the importance of lifecycle management.

Q4: What are the major side effects associated with Cardura XL?
A4: Common adverse effects include orthostatic hypotension, dizziness, fatigue, and nasal congestion—effects generally manageable with proper dosing.

Q5: How might future digital health trends impact Cardura XL’s market?
A5: Digital adherence tools could improve patient compliance, leading to better outcomes and potential differentiation in a competitive landscape.

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References

[1] Post-marketing surveillance data, FDA Adverse Event Reporting System, 2022.
[2] GlobalData, "Benign Prostatic Hyperplasia Market Report," 2022.
[3] MarketWatch, "Pharmaceuticals: Alpha-Blockers Market Outlook," 2023.
[4] IMS Health, "Regional Growth Dynamics in BPH Treatments," 2022.

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In conclusion, while Cardura XL maintains its established position in the BPH and hypertension treatment markets, ongoing clinical trials primarily reinforce its known safety and efficacy profile. Market growth will depend on patent status, competitive innovations, and strategic positioning in emerging regions and healthcare delivery models.