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.
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.

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
Pheochromocytoma	2
Alcohol Drinking	2
Substance-Related Disorders	2

Clinical Trial Locations for Cardura Xl

Trials by Country

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

Trials by US State

Trials by US State for Cardura Xl
Location	Trials
Texas	3
Colorado	2
California	2
Connecticut	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
Yale University	1

Sponsor Type

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

CARDURA XL: Clinical Trials, Market Analysis, and Projections

Introduction

CARDURA XL, an extended-release formulation of doxazosin mesylate, is a medication primarily indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Study Design and Population

The efficacy and safety of CARDURA XL were evaluated in two major clinical trials, Study 1 and Study 2, involving a total of 1475 patients with symptomatic BPH. These studies were randomized, double-blind, and active-controlled, comparing CARDURA XL with doxazosin immediate release (IR) and placebo over 13 weeks[1][2].

Dosing and Efficacy

In both studies, CARDURA XL was initiated at a dose of 4 mg per day, which could be increased to 8 mg after seven weeks if an adequate response was not observed. The primary efficacy variables included the International Prostate Symptom Score (IPSS) and the maximum urinary flow rate. The results showed statistically significant improvements in both IPSS and maximum urinary flow rate for patients treated with CARDURA XL compared to placebo[1][2].

Adverse Reactions

The most commonly reported adverse reactions leading to discontinuation in the CARDURA XL group included dizziness, dyspnea, asthenia, headache, hypotension, postural hypotension, and somnolence. The rates of discontinuation due to adverse events were 6% for CARDURA XL, 7% for doxazosin IR, and 3% for placebo[1][2].

Market Analysis

Current Market Status

CARDURA XL is currently marketed by Viatris and was approved by the FDA on February 22, 2005. Despite its long-standing presence in the market, there is no therapeutically equivalent generic version of CARDURA XL available in the United States as of the latest updates[4].

Market Demand

The demand for BPH treatments is significant and growing due to the increasing prevalence of the condition, particularly among aging populations. CARDURA XL, with its extended-release formulation, offers a convenient once-daily dosing regimen, which can enhance patient compliance and satisfaction.

Competitive Landscape

The BPH treatment market is competitive, with several other medications available, including alpha-blockers like tamsulosin and 5-alpha reductase inhibitors like finasteride. However, CARDURA XL's unique extended-release mechanism and its ability to treat both BPH and hypertension in some patients make it a valuable option in the therapeutic arsenal.

Projections and Future Outlook

Market Growth

The global BPH treatment market is expected to grow due to factors such as an aging population, increasing awareness of BPH, and advancements in treatment options. CARDURA XL is likely to benefit from this growth, especially in regions where access to healthcare is improving.

Generic Competition

Although there is currently no generic version of CARDURA XL available, the potential for future generic competition could impact market share. However, the lack of a generic equivalent as of now allows CARDURA XL to maintain its market position without immediate generic competition[4].

Regulatory and Safety Considerations

CARDURA XL is contraindicated in patients with a known sensitivity to doxazosin or other quinazolines, and it carries warnings for postural hypotension and other adverse effects. Continued monitoring of safety data and adherence to regulatory guidelines will be crucial for maintaining its market presence.

Key Takeaways

• Clinical Efficacy: CARDURA XL has demonstrated significant improvements in IPSS and maximum urinary flow rate in clinical trials.
• Market Position: It remains a unique option in the BPH treatment market due to its extended-release formulation and lack of generic competition.
• Future Outlook: The market for BPH treatments is expected to grow, and CARDURA XL is well-positioned to benefit from this trend.
• Regulatory and Safety: Continued vigilance on safety and regulatory compliance is essential.

FAQs

Q: What is the primary indication for CARDURA XL?

A: CARDURA XL is primarily indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)[2].

Q: How is CARDURA XL administered?

A: CARDURA XL is administered as an extended-release tablet, taken once daily, with doses of either 4 mg or 8 mg[2].

Q: What are the common adverse reactions associated with CARDURA XL?

A: Common adverse reactions include dizziness, dyspnea, asthenia, headache, hypotension, postural hypotension, and somnolence[1][2].

Q: Is there a generic version of CARDURA XL available?

A: No, there is currently no therapeutically equivalent generic version of CARDURA XL available in the United States[4].

Q: Can CARDURA XL be used to treat hypertension?

A: While CARDURA XL can be used in patients with hypertension and BPH, it is not indicated for the treatment of hypertension alone[2].

Sources

1. FDA Label: CARDURA XL - Highlights of Prescribing Information[1].
2. FDA Label: CARDURA XL - Full Label[2].
3. FDA Label: CARDURA - Full Label[3].
4. Drugs.com: Generic Cardura XL Availability[4].
5. Medicines.org.uk: Cardura XL 4mg tablet - Summary of Product Characteristics[5].

Last updated: 2025-01-05