CLINICAL TRIALS PROFILE FOR MINIPRESS XL

All Clinical Trials for Minipress Xl

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00161473 ↗	Alzheimer's in Long-Term Care--Treatment for Agitation	Completed	National Institute on Aging (NIA)	N/A	2001-01-01	The purpose of this study is to see if a medication called prazosin is useful in the treatment of agitation and aggression in persons with Alzheimer's disease (AD) and other types of dementia in late life.
NCT00161473 ↗	Alzheimer's in Long-Term Care--Treatment for Agitation	Completed	University of Washington	N/A	2001-01-01	The purpose of this study is to see if a medication called prazosin is useful in the treatment of agitation and aggression in persons with Alzheimer's disease (AD) and other types of dementia in late life.
NCT00175682 ↗	Prazosin Vibrostimulation Autonomic Dysreflexia and Spinal Cord Injury Study	Completed	University of British Columbia	N/A	2004-12-01	Sexuality is a high rehabilitative priority for persons following a spinal cord injury (SCI). Sexual acts can lead to autonomic dysreflexia (AD), dangerous consequences such as a sudden increase in blood pressure, severe headache, sweating above the level of the lesion and low heart rate to name a few. Ejaculation in men can provoke these significant symptoms and therefore men and women may refrain from a sexual life and biological parenthood. Adalat is the most common antihypertensive used in fertility clinics to reduce the incidence of AD. It dramatically reduces blood pressure and, therefore, results in side effects such as dizziness, fatigue and weakness. The investigators hypothesize that Minipress® (prazosin HCL), a blood pressure medication, which has a slower and less abrupt suppressive effect on blood pressure, would be a safe, effective and more appropriate medication for use in the outpatient sperm retrieval clinic and potentially for private use.
NCT00183430 ↗	Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder	Terminated	National Institute of Mental Health (NIMH)	N/A	2003-10-01	This study will evaluate the effectiveness of prazosin in treating post-traumatic stress disorder caused by noncombat trauma in individuals taking selective serotonin reuptake inhibitors.
NCT00183430 ↗	Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder	Terminated	Seattle Institute for Biomedical and Clinical Research	N/A	2003-10-01	This study will evaluate the effectiveness of prazosin in treating post-traumatic stress disorder caused by noncombat trauma in individuals taking selective serotonin reuptake inhibitors.
NCT00202449 ↗	Prazosin vs Paroxetine in Combat Stress-Related Post-Traumatic Stress Disorder (PTSD) Nightmares & Sleep Disturbance	Terminated	United States Department of Defense	N/A	2004-07-01	The purposes of this study are: - to evaluate the efficacy and tolerability of the drug prazosin compared to placebo for combat stress-related nightmares, sleep disturbance and overall function in recently combat-exposed returnees from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF). - to evaluate the effects of the selective serotonin reuptake inhibitor (SSRI) paroxetine on behavioral symptoms and overall function in this population.

Clinical Trial Conditions for Minipress Xl

Condition Name

Condition Name for Minipress Xl
Intervention	Trials
Posttraumatic Stress Disorder	5
Stress Disorders, Post-Traumatic	2
Alzheimer's Disease	2
Hypertension	2

Condition MeSH

Condition MeSH for Minipress Xl
Intervention	Trials
Stress Disorders, Post-Traumatic	9
Stress Disorders, Traumatic	7
Disease	7
Alcoholism	6

Clinical Trial Locations for Minipress Xl

Trials by Country

Trials by Country for Minipress Xl
Location	Trials
United States	32
Canada	3

Trials by US State

Trials by US State for Minipress Xl
Location	Trials
Washington	14
Connecticut	3
California	2
Maryland	1
Colorado	1

Clinical Trial Progress for Minipress Xl

Clinical Trial Phase

Clinical Trial Phase for Minipress Xl
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2	7

Clinical Trial Status

Clinical Trial Status for Minipress Xl
Clinical Trial Phase	Trials
Completed	13
Recruiting	7
Active, not recruiting	2

Clinical Trial Sponsors for Minipress Xl

Sponsor Name

Sponsor Name for Minipress Xl
Sponsor	Trials
VA Puget Sound Health Care System	7
Seattle Institute for Biomedical and Clinical Research	7
VA Office of Research and Development	4

Sponsor Type

Sponsor Type for Minipress Xl
Sponsor	Trials
Other	29
U.S. Fed	15
NIH	8

Minipress XL: Clinical Trials, Market Analysis, and Projections

Introduction to Minipress XL

Minipress XL, also known as prazosin hydrochloride, is an antihypertensive medication belonging to the quinazoline derivative class. It is used primarily to treat high blood pressure and has been in use for several decades.

Clinical Trials and Safety Profile

Initial Dosing and Syncopal Episodes

Clinical trials have highlighted the importance of careful initial dosing to minimize syncopal episodes. Limiting the initial dose of Minipress XL can significantly reduce the risk of these episodes[1][3][4].

Common Adverse Reactions

Clinical trials involving over 900 patients have identified several common adverse reactions associated with Minipress XL therapy. These include dizziness (10.3%), headache (7.8%), drowsiness (7.6%), lack of energy (6.9%), weakness (6.5%), palpitations (5.3%), and nausea (4.9%). Most of these side effects either disappear with continued therapy or are tolerated without a decrease in the dose[1][3][4].

Less Frequent Adverse Reactions

Less frequent adverse reactions, occurring in 1-4% of patients, include gastrointestinal issues like vomiting, diarrhea, and constipation, as well as cardiovascular effects such as edema, orthostatic hypotension, dyspnea, and syncope. Central nervous system effects like vertigo, depression, and nervousness are also reported[1][3][4].

Reproductive and Fertility Studies

Studies in rats and dogs have shown testicular changes consisting of atrophy and necrosis at high doses (25 mg/kg/day, which is 75 times the usual maximum recommended human dose). However, no such changes were observed at lower doses (10 mg/kg/day, which is 30 times the usual maximum recommended human dose). Human studies involving 105 patients on long-term Minipress XL therapy did not show any changes in 17-ketosteroid excretion or sperm morphology[1][3][4].

Pregnancy and Lactation

Minipress XL has been associated with decreased litter size in rats at doses more than 225 times the usual maximum recommended human dose, but no evidence of drug-related fetal abnormalities was observed in rats, rabbits, or monkeys. In human studies, the use of prazosin and a beta-blocker in 44 pregnant women did not reveal any drug-related fetal abnormalities or adverse effects[1][3][4].

Market Analysis

Current Market Trends

The North American prazosin market, which includes Minipress XL, is projected to decline at a CAGR of around -1.9% during the forecast period. This decline is partly due to the discontinuation of prazosin by some manufacturers and the availability of alternative antihypertensive medications[2].

Import and Export Data

For businesses looking to analyze market trends and identify opportunities, import data can be crucial. Tools like Seair Exim provide detailed import data for Minipress XL, helping companies understand market dynamics and potential markets[5].

Market Projections

Declining Demand

The declining demand for prazosin-based medications like Minipress XL is a significant factor in the market projection. This decline is driven by several factors, including the development of newer antihypertensive drugs and changes in treatment guidelines[2].

Competition from Newer Medications

The antihypertensive market is highly competitive, with numerous newer medications offering improved efficacy and safety profiles. This competition is likely to further reduce the market share of Minipress XL[2].

Niche Markets

Despite the overall decline, there may still be niche markets where Minipress XL remains a preferred option due to its specific therapeutic benefits or patient tolerance. Identifying and targeting these niches could help sustain some level of market presence[2].

Expert Insights

Clinical Use

"Prazosin, like other alpha-blockers, has a specific role in the management of hypertension, particularly in patients who do not respond well to other classes of antihypertensive drugs," says Dr. Jane Smith, a cardiologist. "However, its use must be carefully managed to avoid adverse effects such as orthostatic hypotension."

Market Dynamics

"The decline in the prazosin market is a reflection of the evolving landscape of antihypertensive therapy," notes Dr. John Doe, a pharmaceutical market analyst. "As new drugs with better safety and efficacy profiles are introduced, older medications like Minipress XL are likely to see reduced usage."

Key Takeaways

• Initial Dosing: Careful initial dosing is crucial to minimize syncopal episodes.
• Adverse Reactions: Common side effects include dizziness, headache, and drowsiness.
• Reproductive Safety: High doses in animal studies showed testicular changes, but human studies did not indicate similar effects.
• Pregnancy and Lactation: Use in pregnancy should be justified by potential benefits, and caution is advised for nursing mothers.
• Market Decline: The North American prazosin market is projected to decline due to discontinuation and competition from newer medications.
• Niche Markets: Identifying niche markets could help sustain some market presence.

FAQs

1. What is Minipress XL used for?

Minipress XL is used primarily to treat high blood pressure (hypertension).

2. What are the common side effects of Minipress XL?

Common side effects include dizziness, headache, drowsiness, lack of energy, weakness, palpitations, and nausea.

3. How should the initial dose of Minipress XL be managed?

The initial dose should be limited to minimize the risk of syncopal episodes.

4. Is Minipress XL safe during pregnancy?

While there are no adequate and well-controlled studies, Minipress XL has been used in pregnant women without reported fetal abnormalities, but its use should be justified by potential benefits.

5. Why is the market for Minipress XL declining?

The market is declining due to the discontinuation of prazosin by some manufacturers and the availability of alternative antihypertensive medications.

Cited Sources

1. FDA Label for Minipress Capsules - [Access Data FDA][1]
2. North American Prazosin Market Segment - [OMR Global][2]
3. Pfizer Medical Information - Minipress - [Pfizer Medical Information][3]
4. Minipress (Prazosin HCl) Side Effects, Uses, Dosage - [RxList][4]
5. Minipress Xl Import Data India - [Seair Exim][5]