CLINICAL TRIALS PROFILE FOR HYDRALAZINE HYDROCHLORIDE

All Clinical Trials for hydralazine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	Centers for Disease Control and Prevention	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Eye Institute (NEI)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute on Aging (NIA)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000499 ↗	Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)	Completed	National Institute on Aging (NIA)	Phase 2	1980-09-01	The SHEP Pilot Study had six objectives, each designed to develop and test critical components of a full scale trial directed at the health consequences of treating isolated systolic hypertension (ISH) in the elderly. l. To estimate and compare the yield of participants for randomization into a clinical trial from various community groups using various recruitment techniques. 2. To estimate compliance with the visit schedule and to the prescribed double-blind regimens. 3. To estimate and compare the effectiveness of specified antihypertensive medications in reducing the blood pressure. 4. To estimate and compare the unwanted effects of specified antihypertensive medication in an elderly population. 5. To evaluate the feasibility and effectiveness of periodic behavioral assessment in this population. 6. To develop and test methods of ascertaining stroke and other disease endpoints.
NCT00000499 ↗	Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1980-09-01	The SHEP Pilot Study had six objectives, each designed to develop and test critical components of a full scale trial directed at the health consequences of treating isolated systolic hypertension (ISH) in the elderly. l. To estimate and compare the yield of participants for randomization into a clinical trial from various community groups using various recruitment techniques. 2. To estimate compliance with the visit schedule and to the prescribed double-blind regimens. 3. To estimate and compare the effectiveness of specified antihypertensive medications in reducing the blood pressure. 4. To estimate and compare the unwanted effects of specified antihypertensive medication in an elderly population. 5. To evaluate the feasibility and effectiveness of periodic behavioral assessment in this population. 6. To develop and test methods of ascertaining stroke and other disease endpoints.

Clinical Trial Conditions for hydralazine hydrochloride

Condition Name

Condition Name for hydralazine hydrochloride
Intervention	Trials
Hypertension	12
Heart Failure	6
Postoperative Pain	4
Hypertension in Pregnancy	3

Condition MeSH

Condition MeSH for hydralazine hydrochloride
Intervention	Trials
Hypertension	18
Heart Failure	11
Pre-Eclampsia	10
Hypertension, Pregnancy-Induced	8

Clinical Trial Locations for hydralazine hydrochloride

Trials by Country

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Trials by Country for hydralazine hydrochloride
Location	Trials
United States	62
Mexico	6
Canada	4
Hong Kong	3
Spain	2

Trials by US State

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−

Trials by US State for hydralazine hydrochloride
Location	Trials
Tennessee	7
New York	6
Ohio	5
Massachusetts	3
New Jersey	3

Clinical Trial Progress for hydralazine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for hydralazine hydrochloride
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	14
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for hydralazine hydrochloride
Clinical Trial Phase	Trials
Completed	32
Unknown status	11
Recruiting	10

Clinical Trial Sponsors for hydralazine hydrochloride

Sponsor Name

Sponsor Name for hydralazine hydrochloride
Sponsor	Trials
National Institute of Cancerología	6
Psicofarma S.A. de C.V.	5
Vanderbilt University Medical Center	4

Sponsor Type

Sponsor Type for hydralazine hydrochloride
Sponsor	Trials
Other	99
NIH	9
Industry	7

Hydralazine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Hydralazine hydrochloride, a well-established antihypertensive agent, has been gaining attention for its potential in treating other medical conditions, most notably Alzheimer's Disease (AD). This article delves into the current clinical trials, market analysis, and future projections for hydralazine hydrochloride.

Clinical Trials: Evaluating Hydralazine in Alzheimer's Disease

Trial Design and Objectives

A significant clinical trial is underway to assess the efficacy of hydralazine in patients with mild to moderate Alzheimer's Disease. This randomized, triple-blind, placebo-controlled trial aims to evaluate the effects of hydralazine on cognitive function over a 12-month period. The trial involves 424 patients aged 50 and older, who will be randomly assigned to receive either hydralazine HCL (25 mg, three times daily) or a placebo[1][4].

Mechanisms of Action

Hydralazine has shown promising neuroprotective properties in animal models of AD. It activates the Nrf2 pathway, which controls over 200 antioxidant proteins, rejuvenates mitochondria, and activates autophagy, all of which are crucial for mitigating the progression of AD[4].

Primary and Secondary Outcomes

The primary outcome of the trial is the change in the Alzheimer's Disease Assessment Scale (ADAS-cog) from baseline to 12 months. Secondary outcomes include assessments using the Lawton instrumental activities of daily living scale, neuropsychiatry inventory, and caregiver activity survey[1][4].

Limitations and Future Directions

While this trial is the first to examine hydralazine's impact on mild to moderate AD in humans, it has several limitations. These include the lack of biomarker assays, the inherent homogeneity of the AD cohort, and the unpredictable progression of the disease. The trial may not elucidate the long-term effects of hydralazine beyond the 12-month period[1].

Market Analysis: Current Trends and Growth Projections

Market Size and Growth

The global hydralazine hydrochloride market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.5% during the forecast period from 2023 to 2031. This growth is driven primarily by the rising prevalence of hypertension and heart diseases worldwide[5].

Market Segmentation

The market is segmented based on type (purity levels of ≥99.5% and ≥99.9%), application (tablets and injection solutions), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2][5].

Key Drivers and Restraints

The increasing geriatric population and the high prevalence of hypertension are major drivers of the market. According to the World Health Organization (WHO), approximately 1.13 billion people worldwide suffer from hypertension. However, the market growth is restrained by the high cost of alternative medications and the potential side effects of hydralazine, such as low blood pressure, headache, and in rare cases, heart problems and lupus-like syndrome[5].

Distribution Channels and Competitive Landscape

The market is classified into hospital pharmacies, retail pharmacies, and online pharmacies, with hospital pharmacies expected to grow significantly. Key players in the hydralazine market include Novartis, Akorn, American Regent, Troikaa Pharmaceuticals, and Zafa Pharmaceuticals, among others. The competitive landscape is intensified by increasing research and development activities and strategic business expansions[5].

Regional Outlook

Global Distribution

The hydralazine market is spread across various regions, with North America, Europe, and Asia-Pacific being significant contributors. The tablet form of hydralazine is widely used in these regions for treating hypertension and heart failure[2][5].

Regional Growth Factors

In the U.S., hypertension affects approximately 75 million adults, driving the demand for hydralazine. In the UK, hydralazine is available in 25 mg and 50 mg tablets, further boosting the market. The increasing geriatric population and changes in lifestyle are also contributing to the market growth in these regions[5].

Future Projections

Continued Growth

The hydralazine market is poised for significant growth due to the persistent rise in hypertension and heart diseases. The availability of generic hydralazine and its cost-effectiveness compared to alternative medications will continue to drive market expansion[5].

Emerging Applications

The potential use of hydralazine in treating Alzheimer's Disease could open new avenues for market growth. Successful outcomes from the ongoing clinical trials could lead to expanded indications and increased demand for the drug[1][4].

Key Takeaways

• Clinical Trials: Ongoing trials are evaluating hydralazine's efficacy in mild to moderate Alzheimer's Disease, focusing on cognitive function and other secondary outcomes.
• Market Growth: The global hydralazine market is expected to grow at a CAGR of 3.5% from 2023 to 2031, driven by the rising prevalence of hypertension and heart diseases.
• Market Segmentation: The market is segmented by type, application, and geographical regions, with hospital pharmacies and tablet forms being significant segments.
• Competitive Landscape: Key players are intensifying the competitive landscape through research and development and strategic expansions.
• Future Projections: The market is expected to continue growing, with potential new applications in treating Alzheimer's Disease.

FAQs

Q: What is the primary objective of the ongoing clinical trial involving hydralazine in Alzheimer's Disease?

A: The primary objective is to assess the efficacy of hydralazine in improving cognitive function in patients with mild to moderate Alzheimer's Disease over a 12-month period[1][4].

Q: What are the key mechanisms through which hydralazine may benefit Alzheimer's Disease patients?

A: Hydralazine activates the Nrf2 pathway, rejuvenates mitochondria, and activates autophagy, all of which are crucial for mitigating the progression of Alzheimer's Disease[4].

Q: What is the expected growth rate of the global hydralazine market from 2023 to 2031?

A: The global hydralazine market is expected to grow at a CAGR of 3.5% during the forecast period from 2023 to 2031[5].

Q: Which segments are driving the growth of the hydralazine market?

A: The tablet form and hospital pharmacies are significant segments driving the market growth. The increasing geriatric population and high prevalence of hypertension are also key drivers[5].

Q: What are some potential side effects of hydralazine?

A: Hydralazine can cause side effects such as low blood pressure, headache, rash, and dizziness. In rare cases, more serious side effects like heart problems and lupus-like syndrome can occur[5].

Sources

1. PubMed: "A randomized clinical trial evaluating Hydralazine's efficacy in early-stage Alzheimer's disease" (2024)
2. Market Research Intellect: "Global Hydralazine HCL Market Size, Scope And Forecast Report" (2024)
3. AHDB Online: "Communication Strategies Must Be Tailored to a Medication's Targeted Population: Lessons from the Case of BiDil" (2013)
4. ClinicalTrials.Veeva: "Effect of Hydralazine on Alzheimer's Disease - ClinicalTrials.Veeva" (2022)
5. Biospace: "Global Hydralazine Market to Grow at a CAGR of 3.5% During Forecast Period - Emergen Research" (2022)