CLINICAL TRIALS PROFILE FOR PRAZOSIN HYDROCHLORIDE

505(b)(2) Clinical Trials for Prazosin Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00487032 ↗	Differential Adrenoreceptor Mediated Tachyphylaxis and Upregulation	Completed	Brian J Lipworth	Phase 4	2008-05-01	The investigators wish to evaluate the onset of tolerance to nasal decongestants like oxymetazoline (available over the counter) and the mechanism of tolerance particularly with differential effects on alpha 1 and alpha 2 adrenoreceptors on the nose. The investigators will 'tease' out by using an alpha 1 blocker called Prazosin. The investigators hypothesize that alpha 1 receptors mediate arterial constriction and this will be captured by measuring nasal blood flow. The investigators also hypothesize that alpha 2 receptors mediate venous sinusoid constriction and this the investigators will capture by airflow parameters like Peak Nasal Inspiratory Flow, Rhinomanometry, Oscillometric indices etc.

All Clinical Trials for Prazosin Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00108420 ↗	Prazosin Treatment for Combat Trauma PTSD (Post-Traumatic Stress Disorder) Nightmares and Sleep Disturbance	Completed	US Department of Veterans Affairs	Phase 4	2003-10-01	The purpose of this study is to determine whether prazosin will reduce the incidence of nightmares, sleep disturbance, and overall symptoms in combat trauma-exposed individuals with PTSD.
NCT00108420 ↗	Prazosin Treatment for Combat Trauma PTSD (Post-Traumatic Stress Disorder) Nightmares and Sleep Disturbance	Completed	VA Office of Research and Development	Phase 4	2003-10-01	The purpose of this study is to determine whether prazosin will reduce the incidence of nightmares, sleep disturbance, and overall symptoms in combat trauma-exposed individuals with PTSD.

Clinical Trial Conditions for Prazosin Hydrochloride

Condition Name

Condition Name for Prazosin Hydrochloride
Intervention	Trials
Posttraumatic Stress Disorder	9
Stress Disorders, Post-Traumatic	7
PTSD	7
Alcohol Use Disorder	5

Condition MeSH

Condition MeSH for Prazosin Hydrochloride
Intervention	Trials
Stress Disorders, Post-Traumatic	25
Stress Disorders, Traumatic	18
Alcoholism	17
Disease	17

Clinical Trial Locations for Prazosin Hydrochloride

Trials by Country

Trials by Country for Prazosin Hydrochloride
Location	Trials
United States	94
Canada	5
France	3
United Kingdom	2
Spain	1

Trials by US State

Trials by US State for Prazosin Hydrochloride
Location	Trials
Washington	22
California	6
Connecticut	5
Georgia	4
Pennsylvania	4

Clinical Trial Progress for Prazosin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Prazosin Hydrochloride
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	6
Phase 2	15

Clinical Trial Status

Clinical Trial Status for Prazosin Hydrochloride
Clinical Trial Phase	Trials
Completed	36
Recruiting	11
Withdrawn	5

Clinical Trial Sponsors for Prazosin Hydrochloride

Sponsor Name

Sponsor Name for Prazosin Hydrochloride
Sponsor	Trials
VA Office of Research and Development	12
Seattle Institute for Biomedical and Clinical Research	9
VA Puget Sound Health Care System	9

Sponsor Type

Sponsor Type for Prazosin Hydrochloride
Sponsor	Trials
Other	64
U.S. Fed	36
NIH	17

Prazosin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Prazosin Hydrochloride

Prazosin hydrochloride, commonly known by the brand name Minipress, is a medication primarily used to treat hypertension (high blood pressure) and heart failure. It is also utilized for other conditions such as prostate disorders and neurological syndromes. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Recent Study on Manufacturing Sites

A recent clinical study conducted by Pfizer aimed to compare the bioavailability of prazosin hydrochloride capsules manufactured at two different sites: Barceloneta in Puerto Rico and Ascoli in Italy. The study involved healthy adult participants who were administered the same doses of prazosin HCl from both manufacturing sites. The results showed minor differences in the area under the concentration-time curve (AUClast) for the Barceloneta site, but meaningful differences in the maximum concentration (Cmax) for the Ascoli site. However, these differences were not considered clinically significant, indicating that the drug's efficacy and safety profile remain consistent across different manufacturing sites[2].

Adverse Reactions and Safety Profile

Clinical trials and post-marketing experience have highlighted several common adverse reactions associated with prazosin hydrochloride therapy. These include dizziness, headache, drowsiness, lack of energy, weakness, palpitations, and nausea. Less frequent reactions involve gastrointestinal, cardiovascular, and central nervous system issues. Despite these side effects, most patients tolerate the drug well with continued therapy or without a decrease in dose[4].

Long-Term Studies

Long-term studies in rats and dogs have shown testicular changes such as atrophy and necrosis at high doses, but these effects were not observed in humans. Clinical trials involving over 900 patients did not indicate any significant changes in sperm morphology or 17-ketosteroid excretion, suggesting that prazosin hydrochloride is safe for long-term use in humans[4].

Market Analysis

Market Size and Growth

The global prazosin hydrochloride market has experienced mixed trends. While the market size is anticipated to grow in certain segments, overall projections indicate a negative Compound Annual Growth Rate (CAGR) of around 2% during the forecast period. This decline is attributed to factors such as the presence of alternative drugs, discontinuation of prazosin manufacturing by some companies, unfavorable reimbursement policies, and associated side effects[3].

Market Segmentation

The market is segmented based on type (pharmaceutical grade and industrial grade) and application (bases & related reagents, pharmaceuticals, intermediates & fine chemicals). Geographically, the market is analyzed across regions including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America is expected to hold the largest market share due to the high cost of drugs and significant sales of branded drugs, particularly those by Pfizer[1][3].

Key Players

Major players in the prazosin hydrochloride market include Pfizer Inc., Mylan N.V., Merck KGaA, Teva Pharmaceuticals Industries Ltd., and Apotex Inc. These companies are adopting strategies such as new product launches, mergers, and acquisitions to maintain their competitive edge. For instance, Pfizer and Mylan N.V. merged to form Viatris, a move aimed at enhancing their market presence[3].

Market Projections

Future Outlook

Despite the negative CAGR, the prazosin hydrochloride market is expected to see some growth driven by factors such as the increasing prevalence of cardiovascular diseases (CVDs) and rising awareness towards mental health. The market will be influenced by the ongoing demand for hypertension treatment and the use of prazosin hydrochloride in other therapeutic areas like neurological syndromes and prostate disorders[3].

Regional Analysis

North America will continue to dominate the market due to high drug costs and significant sales of branded drugs. The Asia-Pacific region is also expected to show growth, driven by an increasing patient pool and improving healthcare infrastructure[3].

Competitive Landscape

The competitive landscape will remain dynamic with key players focusing on strategic alliances, product innovations, and market expansion. The formation of new companies, such as Viatris, will play a significant role in shaping the market's future[3].

Key Takeaways

• Clinical Trials: Recent studies have confirmed the bioequivalence of prazosin hydrochloride capsules from different manufacturing sites, ensuring consistent efficacy and safety.
• Market Analysis: The global prazosin hydrochloride market is projected to exhibit a negative CAGR due to the presence of alternative drugs and other market challenges.
• Market Segmentation: The market is segmented by type, application, and geography, with North America holding the largest market share.
• Key Players: Major pharmaceutical companies are adopting various strategies to maintain their market position.
• Future Outlook: Despite challenges, the market will see growth driven by the increasing prevalence of CVDs and other therapeutic applications.

FAQs

What is the primary use of prazosin hydrochloride?

Prazosin hydrochloride is primarily used to treat hypertension (high blood pressure) and heart failure.

What were the findings of the recent clinical study on prazosin hydrochloride manufacturing sites?

The study found minor differences in bioavailability between capsules manufactured at different sites, but these differences were not clinically significant[2].

What are the common adverse reactions associated with prazosin hydrochloride therapy?

Common adverse reactions include dizziness, headache, drowsiness, lack of energy, weakness, palpitations, and nausea[4].

Which region is expected to dominate the prazosin hydrochloride market?

North America is expected to hold the largest market share due to high drug costs and significant sales of branded drugs[3].

What are the key factors influencing the growth of the prazosin hydrochloride market?

The market is influenced by the increasing prevalence of CVDs, rising awareness towards mental health, and the presence of alternative drugs and unfavorable reimbursement policies[3].

Sources

1. Market Research Intellect: Prazosin Hydrochloride Market Size, Scope And Forecast Report.
2. Pfizer: Clinical Study Results - Prazosin HCl.
3. OMR Global: Prazosin Market Share, Size | Industry Analysis and Forecast 2020.
4. Pfizer Labeling: Prazosin Hydrochloride Capsules.

Last updated: 2025-01-01