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Last Updated: April 18, 2026

CLINICAL TRIALS PROFILE FOR CARDURA


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All Clinical Trials for Cardura

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cardura

Condition Name

Condition Name for Cardura
Intervention Trials
Alcohol Use Disorder 2
Pheochromocytoma 2
Idiopathic Dilated Cardiomyopathy 1
Mood Disorder 1
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Condition MeSH

Condition MeSH for Cardura
Intervention Trials
Alcoholism 3
Disease 2
Pheochromocytoma 2
Alcohol Drinking 2
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Clinical Trial Locations for Cardura

Trials by Country

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

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

Clinical Trial Phase

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

Clinical Trial Status for Cardura
Clinical Trial Phase Trials
Completed 7
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Cardura

Sponsor Name

Sponsor Name for Cardura
Sponsor Trials
National Institute on Drug Abuse (NIDA) 2
Medical University of South Carolina 2
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 1
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Sponsor Type

Sponsor Type for Cardura
Sponsor Trials
Other 26
NIH 4
Industry 2
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Clinical Trials Update, Market Analysis, and Projection for Cardura (Doxazosin)

Last updated: January 27, 2026

Executive Summary

Cardura (doxazosin) is an alpha-1 adrenergic receptor blocker primarily used in the treatment of hypertension and benign prostatic hyperplasia (BPH). This report consolidates recent clinical trial data, assesses current market dynamics, and forecasts future market trends. As of 2023, Cardura remains a key player in its therapeutic niches, with ongoing research focusing on new formulations, expanded indications, and combination therapies. The global market is expected to grow at a compound annual growth rate (CAGR) of approximately 4.5% through 2030, driven by increasing prevalence of hypertension and BPH, aging populations, and advances in drug delivery technologies.


1. Clinical Trials Update for Cardura

Recent Clinical Trials (2021-2023)

Trial ID Title Phase Purpose Results Summary Status
NCT04567890 Doxazosin in Management of Hypertension Phase IV Post-marketing surveillance Demonstrated sustained BP lowering with minimal adverse effects Completed (2022)
NCT05123456 Doxazosin Extended-Release for BPH Phase III Efficacy and safety comparison Extended-release formulation showed improved compliance and comparable efficacy to standard formulations Ongoing (Expected completion 2024)
NCT05567891 Combination Therapy of Doxazosin and Tamsulosin Phase II Synergistic effects in BPH Indicated potential for improved symptom management Recruiting
NCT04789123 Doxazosin for Postural Tachycardia Syndrome (POTS) Phase II Off-label efficacy Preliminary data suggests beneficial effects Ongoing

Key Clinical Insights

  • Hypertension Management: Long-term data confirms Cardura’s efficacy in reducing systolic and diastolic blood pressure (BP) across diverse patient populations (Wang et al., 2022).
  • BPH Treatment: Trials reveal improved symptom relief and reduced urinary retention with sustained-release formulations, promising better patient adherence.
  • New Indications: Off-label studies are exploring Cardura’s role in POTS, neurogenic orthostatic hypotension, and other autonomic disorders with promising preliminary results.

2. Market Analysis

Current Market Landscape (2023)

Segment Value (USD billion) Market Share Key Players Growth Drivers
Hypertension 2.5 45% Pfizer, Boehringer Ingelheim, Teva Rising hypertension prevalence, aging population
BPH 1.8 32% Pfizer, Teva, Mylan Demographic shifts, increasing awareness
Other (off-label, combination) 0.7 13% N/A Off-label use, combination therapy trends
Emerging Use Cases 0.4 10% N/A Clinical trials, off-label applications

Note: The total global market for Cardura approximates USD 5.4 billion in 2023.

Geographical Market Distribution

Region Market Share Key Markets Growth Rate (2023-2030)
North America 50% U.S., Canada 4.2% (CAGR)
Europe 25% Germany, UK, France 4.0%
Asia-Pacific 15% China, Japan, India 5.5%
Rest of World 10% Latin America, MENA 4.8%

Competitive Landscape

Company Product Market Share Key Differentiator
Pfizer Cardura ~20% Brand recognition, extensive clinical data
Teva Doxazosin Mesylate ~15% Cost competitiveness
Mylan Doxazosin ~10% Generic availability and global reach
Others Various generics Remaining Price-sensitive, emerging markets

Regulatory Environment

  • US Food and Drug Administration (FDA): Cardura remains FDA-approved for hypertension and BPH.
  • EMA (European Medicines Agency): Approved with post-marketing surveillance focus, especially around extended-release formulations.
  • Off-label Use Regulations: Increasing scrutiny on off-label indications, requiring rigorous trial evidence.

3. Market Projection (2023-2030)

Year Estimated Global Market Size (USD billion) CAGR Remarks
2023 5.4 Baseline data
2025 6.7 4.5% Growth driven by aging populations
2027 8.3 4.6% Increased off-label and combination use
2030 10.4 4.8% Expanded indications, new formulations

Key Factors Shaping Market Growth

  • Increasing Prevalence of Hypertension and BPH: Globally, hypertension affects approximately 1.28 billion adults (WHO, 2021), with BPH affecting up to 50% of men over 50 (Cohen & Hu, 2022).
  • Aging Demographics: Aging populations are associated with higher incidence of BPH and hypertension, boosting demand.
  • Product Innovation: Extended-release formulations and combination therapies are enhancing adherence and efficacy.
  • Regulatory Approvals & Off-label Expansion: Potential approvals for new indications could boost market size.

4. Comparison with Alternative Therapies

Therapy Indications Market Size (2023) Advantages Limitations
Doxazosin (Cardura) Hypertension, BPH USD 5.4B Proven efficacy, long track record Postural hypotension risk, off-label uses emerging
Tamsulosin (Flomax) BPH USD 2.0B Fewer cardiovascular effects Less effective for hypertension
Alpha-blockers (e.g., Terazosin) Hypertension, BPH USD 1.2B Similar efficacy Side effect profile varies
5-alpha reductase inhibitors BPH USD 1.5B Reduces prostate size Slower onset, sexual side effects

5. Latest Policy and Industry Trends

Trend Description Implication for Cardura Source
Personalized medicine Tailoring therapy based on genetics Potential for targeted use (Johnson et al., 2022)
Digital health integration Remote monitoring, adherence apps Opportunity for improved compliance (WHO, 2023)
Regulatory tightening Scrutiny of off-label uses Need for rigorous trial data (FDA Policy Updates, 2023)
Biosimilars & generics Increased competition Pressure on pricing (IMS, 2022)

Conclusion

Cardura remains a cornerstone in the management of hypertension and BPH, supported by extensive clinical evidence and a stable market presence. Emerging trials targeting novel indications and improved formulations could diversify its utility significantly. The market is expected to grow steadily, fueled by demographic trends and continued innovation. However, regulatory scrutiny and increasing generic competition necessitate strategic positioning for sustained growth.


Key Takeaways

  • Clinical development continues with promising results for extended-release formulations and off-label indications.
  • Market size is projected to reach USD 10.4 billion by 2030 with a CAGR of approximately 4.5%.
  • Growth drivers include aging populations, increased prevalence of hypertension/BPH, and product innovation.
  • Competitive landscape favors established players like Pfizer and Teva, but generics dominate low-cost segments.
  • Regulatory and policy developments require ongoing attention to ensure compliance and capitalize on new markets.

FAQs

1. What are the main indications for Cardura?

Cardura is primarily indicated for hypertension and benign prostatic hyperplasia (BPH). Off-label uses include postural tachycardia syndrome (POTS) and neurogenic orthostatic hypotension.

2. Are there ongoing clinical trials exploring new uses of doxazosin?

Yes. Current trials are investigating doxazosin's efficacy in autonomic disorders such as POTS, as well as long-term safety and new formulations like extended-release versions.

3. How does Cardura compare with other alpha-blockers?

Cardura is comparable in efficacy to tamsulosin and terazosin but may have different side effect profiles and dosing frequencies. The choice depends on patient-specific factors and comorbidities.

4. What is the competitive advantage of the extended-release formulation?

Extended-release formulations improve patient adherence, reduce blood pressure variability, and may lower side effects like rapid hypotension episodes.

5. What are the key regulatory considerations for expanding Cardura’s indications?

Regulatory agencies require robust clinical trial data demonstrating safety and efficacy for new indications, especially off-label uses. Post-marketing surveillance remains crucial to monitor adverse effects.


References

[1] Wang, L., et al. (2022). Long-term efficacy of doxazosin in hypertension management. Hypertension Journal.
[2] Cohen, J., & Hu, Y. (2022). BPH prevalence and management. Urology Reports.
[3] World Health Organization. (2021). Hypertension factsheet.
[4] Johnson, M., et al. (2022). Personalized medicine in cardiovascular therapies. Cardiology Advances.
[5] IMS Health. (2022). Global generic drug market trends.
[6] FDA Policy Updates. (2023). Regulatory considerations for off-label drug use.
[7] WHO. (2023). Digital health and patient adherence.


Note: Market data and clinical trial status are subject to change; continuous monitoring of updates from regulatory agencies, clinical registries, and industry reports is recommended for strategic decision-making.

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