Last Updated: May 1, 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.
NCT01062945 ↗ The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine Completed Baylor College of Medicine 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.
NCT01379898 ↗ Phenoxybenzamine Versus Doxazosin in PCC Patients Completed Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Phase 4 2011-12-01 - Rationale: The optimal preoperative medical management for patients with a pheochromocytoma is currently unknown. In particular, there is no agreement with respect to whether phenoxybenzamine or doxazosin is the optimal alfa-adrenoreceptor antagonist to be administered before surgical resection of a pheochromocytoma. We hypothesized that the competitive alfa1-antagonist doxazosin is superior to the non-competitive alfa1- and alfa2-antagonist phenoxybenzamine. - Objective: comparing effects of preoperative treatment with either phenoxybenzamine or doxazosin on intraoperative hemodynamic control in patients undergoing surgical resection of a pheochromocytoma. - Study design: Randomised controlled open-label trial. - Study population: 18 - 55 yr old. Adult patients with a recently diagnosed benign pheochromocytoma. - Intervention: Patients are randomised to receive oral treatment with either phenoxybenzamine or doxazosin preoperatively. - Main study parameters/endpoints: The main study parameter is defined as the percentage of intraoperative time that blood pressure is outside the predefined target range after pretreatment with either phenoxybenzamine or doxazosin. In this multicenter trial, we compare the effects of two commonly used drugs in patients being medically prepared for resection of a benign pheochromocytoma. Participants are not subjected to an experimental treatment of any kind, as we merely aim to describe in detail the perioperative course in general and, in particular, the intraoperative hemodynamic control in patients treated preoperatively with either phenoxybenzamine or doxazosin. A routine diagnostic work-up for pheochromocytoma will be performed in all participants. One extra blood sample (volume: 48,5 mL) is drawn before start of the study medication, and participants need to record their symptoms in a diary. In addition, patients who are pretreated in the outpatient clinic monitor their blood pressure and pulse rate at home with an automated device. Treatment with an alfa-adrenoreceptor antagonist is initiated at least 2 - 3 weeks prior to surgery. Patients who are admitted to the hospital for pretreatment with an alfa-adrenoreceptor antagonist have their blood pressure and pulse rate measured by the nursing staff. The final site visit is planned at 30 days after surgery, in line with current practice.
NCT01379898 ↗ Phenoxybenzamine Versus Doxazosin in PCC Patients Completed Atrium Medical Center Phase 4 2011-12-01 - Rationale: The optimal preoperative medical management for patients with a pheochromocytoma is currently unknown. In particular, there is no agreement with respect to whether phenoxybenzamine or doxazosin is the optimal alfa-adrenoreceptor antagonist to be administered before surgical resection of a pheochromocytoma. We hypothesized that the competitive alfa1-antagonist doxazosin is superior to the non-competitive alfa1- and alfa2-antagonist phenoxybenzamine. - Objective: comparing effects of preoperative treatment with either phenoxybenzamine or doxazosin on intraoperative hemodynamic control in patients undergoing surgical resection of a pheochromocytoma. - Study design: Randomised controlled open-label trial. - Study population: 18 - 55 yr old. Adult patients with a recently diagnosed benign pheochromocytoma. - Intervention: Patients are randomised to receive oral treatment with either phenoxybenzamine or doxazosin preoperatively. - Main study parameters/endpoints: The main study parameter is defined as the percentage of intraoperative time that blood pressure is outside the predefined target range after pretreatment with either phenoxybenzamine or doxazosin. In this multicenter trial, we compare the effects of two commonly used drugs in patients being medically prepared for resection of a benign pheochromocytoma. Participants are not subjected to an experimental treatment of any kind, as we merely aim to describe in detail the perioperative course in general and, in particular, the intraoperative hemodynamic control in patients treated preoperatively with either phenoxybenzamine or doxazosin. A routine diagnostic work-up for pheochromocytoma will be performed in all participants. One extra blood sample (volume: 48,5 mL) is drawn before start of the study medication, and participants need to record their symptoms in a diary. In addition, patients who are pretreated in the outpatient clinic monitor their blood pressure and pulse rate at home with an automated device. Treatment with an alfa-adrenoreceptor antagonist is initiated at least 2 - 3 weeks prior to surgery. Patients who are admitted to the hospital for pretreatment with an alfa-adrenoreceptor antagonist have their blood pressure and pulse rate measured by the nursing staff. The final site visit is planned at 30 days after surgery, in line with current practice.
>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
Amphetamine-Related Disorders 1
Prostatic Hypertrophy, Benign 1
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Condition MeSH

Condition MeSH for Cardura
Intervention Trials
Alcoholism 3
Substance-Related Disorders 2
Disease 2
Pheochromocytoma 2
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Clinical Trial Locations for Cardura

Trials by Country

Trials by Country for Cardura
Location Trials
United States 22
Netherlands 1
United Kingdom 1
Switzerland 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
Medisch Spectrum Twente 1
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Sponsor Type

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

Last updated: April 28, 2026

What is Cardura (doxazosin) and what are its current clinical-trial and lifecycle signals?

Cardura is the brand name for doxazosin, an alpha-1 adrenergic receptor blocker used primarily for:

  • Benign prostatic hyperplasia (BPH) (improves urinary symptoms; does not treat the cause of disease)
  • Hypertension (blood-pressure lowering via vascular alpha-1 blockade)

Lifecycle context. Doxazosin is an established, off-patent small-molecule product in most major markets. The practical consequence for “clinical trials update” is that new trials usually occur as:

  • Label expansions or regimen comparisons
  • Bioequivalence studies for generics
  • Methodology or population-specific studies rather than first-in-class development programs

No specific, currently actionable proprietary trial program details can be produced from the information provided. A complete, accurate “trial update” requires trial-by-trial sourcing (e.g., clinicaltrials.gov record IDs, trial statuses, endpoints, enrollment, and dates). Under the constraint of delivering only complete and accurate information, the clinical-trials section below cannot be populated.

What does the market look like for doxazosin/Cardura (demand drivers and pricing dynamics)?

Because Cardura is an established alpha blocker and doxazosin is widely generic, the market behaves like a mature, price-competitive generics segment. Key market drivers and constraints:

Demand drivers

  • BPH prevalence: symptomatic BPH scales with age distribution in major markets
  • Physician treatment switching: stable long-term use of alpha blockers for LUTS (lower urinary tract symptoms) keeps baseline demand
  • Hospital and primary-care prescribing: alpha blockers are standard options alongside 5-alpha-reductase inhibitors and combination therapy

Price and channel dynamics

  • Generic substitution: branded Cardura faces persistent pricing pressure from low-cost generics
  • Formulation competition: multiple generic formulations (IR and extended-release where available by region) typically compress average selling prices
  • Reimbursement pressure: payer formularies in mature markets tend to favor lowest-cost therapeutics within the class

Competitive set (class-level)

In BPH and LUTS, doxazosin competes across alpha blockers and combination regimens:

  • Other alpha-1 blockers: tamsulosin, alfuzosin, silodosin, terazosin
  • Combination approaches (where used): alpha blocker + 5-alpha-reductase inhibitor (e.g., finasteride/dutasteride)

How big is the market and what is the forecast for Cardura specifically?

A “market projection” for Cardura specifically requires granular inputs that were not provided, such as:

  • regional branded vs generic shares
  • unit sales or prescription volumes by formulation and geography
  • historical pricing (net price), reimbursement trends, and brand erosion curves
  • channel mix and contracting cadence

Under the “complete and accurate response” constraint, a numeric forecast for Cardura cannot be responsibly produced from the provided prompt alone.

What scenario framework can be used to project Cardura’s revenue path?

Even without numeric forecasts, Cardura’s revenue trajectory in mature markets typically follows a predictable pattern:

Base forces

  • Share loss to generics continues, driven by automatic substitution and payer preferred tiers
  • Demand stability holds because BPH prevalence grows with demographics
  • Unit elasticity is limited: many patients remain on established regimens long term
  • Net revenue declines can occur even if prescriptions remain stable, due to lower net pricing

Projection structure (useful for investment and budgeting models)

A defensible projection model for Cardura branded revenue generally decomposes into:

Branded revenue = (Total treated population demand) × (Doxazosin share of alpha-blocker class) × (Branded share within doxazosin) × (Net price)

Each factor tends to move independently:

  • Treated population: grows slowly with age structure
  • Class share: fluctuates with guideline preference, tolerability, and tolerability-driven switching
  • Branded share: trends downward with continued generic penetration
  • Net price: trends downward with contracting and interchangeability

Which regulatory and IP realities matter for forward-looking development?

For doxazosin/Cardura, forward-looking value creation usually does not come from primary composition-of-matter exclusivity (mature molecule). Revenue protection more commonly comes from:

  • Formulation lifecycle (extended release vs immediate release where permitted)
  • Regional regulatory strategy (new dosing or label refinements)
  • Manufacturing and supply continuity in key markets

Without specific dossier updates, exclusivity events, or jurisdiction-level regulatory filings supplied in the prompt, no hard IP or exclusivity timeline can be stated here.

Actionable takeaways for R&D and investment decisions

Cardura’s development posture

  • The molecule is mature; new “clinical trial investment” is typically low-margin versus newer protected assets unless it is tied to formulation, regulatory strategy, or new clinical combinations with measurable differentiation.

Cardura’s commercial posture

  • Expect pricing compression to dominate branded economics.
  • Expect demand persistence because BPH is chronic and age-related.

Where value can still be created

  • Manufacturing efficiencies and supply robustness
  • Regional contracting strategy to defend net price
  • Product lifecycle work (formulation, adherence, tolerability)

Key Takeaways

  • Cardura is doxazosin, a mature alpha-1 blocker used for BPH and hypertension.
  • The market is structurally shaped by chronic demand plus generics-driven pricing compression.
  • A precise clinical-trials update and a numeric Cardura-specific forecast require trial and sales/share inputs that are not provided in the prompt; producing them without sourcing would violate the accuracy constraint.
  • For modeling, branded revenue generally tracks: treated demand × doxazosin share × branded share × net price.

FAQs

  1. Is Cardura still actively studied in clinical trials?
    Clinical activity exists for mature alpha blockers, but a trial-status update with dates, endpoints, and outcomes requires sourced trial records that were not provided.

  2. What are Cardura’s main approved indications?
    BPH (urinary symptoms) and hypertension via alpha-1 blockade.

  3. Will branded Cardura revenue grow?
    In mature markets, branded growth is usually constrained by generic substitution; demand stability does not prevent net price erosion.

  4. What competes with Cardura in BPH treatment?
    Other alpha blockers such as tamsulosin, alfuzosin, silodosin, and terazosin, plus combination regimens in some patients.

  5. How should Cardura be projected in an investment model?
    Use a decomposition model (demand × class share × branded share × net price) rather than a single linear growth assumption.


References

[1] FDA. Cardura (doxazosin) prescribing information. (Product label).
[2] DailyMed. Cardura (doxazosin mesylate) label information. (Product label).
[3] ClinicalTrials.gov. Doxazosin search results and trial records. (Trial record database).

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