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Last Updated: June 20, 2025

CLINICAL TRIALS PROFILE FOR ALDOMET


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All Clinical Trials for Aldomet

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00329511 ↗ A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy Withdrawn Afshan B. Hameed, M.D. N/A 2004-09-01 High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is associated with an increased risk of development of pregnancy related high BP called preeclampsia, preterm delivery, decreased growth of the fetus, fetal death, premature separation of the placenta from the uterus resulting in damage to the fetus and cesarean delivery. Longer duration and severity of CHTN in pregnancy leads to worse outcomes for the mother and the fetus. Treatment of mild CHTN in pregnancy does not improve these outcomes, and therefore, medications to lower BP are used for moderate to severe hypertension. To date the literature on the medications used in pregnancy is extremely limited. Methyldopa is used as a first choice medicine for CHTN in pregnancy. It acts on the central nervous system (CNS) by relaxation of the blood vessels leading to a decrease in BP. It does not decrease the blood flow to the uterus, placenta, or the fetus (4). Methyldopa is a weak antihypertensive medicine given three or four times a day and frequently needs changes in the dose or may require an additional medication to control BP. This may lead to a greater chance of non compliance. Another option is Clonidine which is an effective antihypertensive treatment and is available in many forms (oral, parenteral, and transdermal.) It acts on the maternal CNS. Clonidine is not associated with teratogenic or neonatal side effects. Transdermal clonidine (catapres-TTS®) is a preparation of clonidine hydrochloride that can be released and absorbed transdermally over a 7-day period. The study will determine differences in compliance between the two antihypertensive regimens- oral methyldopa and Catapres-TTS, comparisons of patient tolerability, compliance and adequacy of BP control, as well as provide information on an alternate option for BP control.
NCT00329511 ↗ A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy Withdrawn University of California, Irvine N/A 2004-09-01 High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is associated with an increased risk of development of pregnancy related high BP called preeclampsia, preterm delivery, decreased growth of the fetus, fetal death, premature separation of the placenta from the uterus resulting in damage to the fetus and cesarean delivery. Longer duration and severity of CHTN in pregnancy leads to worse outcomes for the mother and the fetus. Treatment of mild CHTN in pregnancy does not improve these outcomes, and therefore, medications to lower BP are used for moderate to severe hypertension. To date the literature on the medications used in pregnancy is extremely limited. Methyldopa is used as a first choice medicine for CHTN in pregnancy. It acts on the central nervous system (CNS) by relaxation of the blood vessels leading to a decrease in BP. It does not decrease the blood flow to the uterus, placenta, or the fetus (4). Methyldopa is a weak antihypertensive medicine given three or four times a day and frequently needs changes in the dose or may require an additional medication to control BP. This may lead to a greater chance of non compliance. Another option is Clonidine which is an effective antihypertensive treatment and is available in many forms (oral, parenteral, and transdermal.) It acts on the maternal CNS. Clonidine is not associated with teratogenic or neonatal side effects. Transdermal clonidine (catapres-TTS®) is a preparation of clonidine hydrochloride that can be released and absorbed transdermally over a 7-day period. The study will determine differences in compliance between the two antihypertensive regimens- oral methyldopa and Catapres-TTS, comparisons of patient tolerability, compliance and adequacy of BP control, as well as provide information on an alternate option for BP control.
NCT00580619 ↗ Autonomic Nervous System and Chronic Fatigue Syndrome Completed Vanderbilt University Phase 1 2007-04-01 The investigators propose to test the hypothesis that the sympathetic nervous system contributes to the cardiovascular and inflammatory abnormalities present in the chronic fatigue syndrome (CFS) and, in particular in the subset of patients characterized by postural tachycardia syndrome (POTS). CFS and POTS are seen mostly in otherwise normal young women, and are the cause of significant disability. A substantial proportion of patients referred for evaluation of POTS met diagnostic criteria for CFS and, conversely, a subset of patients referred for treatment for CFS have POTS. The investigators hypothesize that sympathetic activation underlies the pathophysiology of patients in whom CFS and POTS overlap (CFS-P).
NCT00580619 ↗ Autonomic Nervous System and Chronic Fatigue Syndrome Completed Vanderbilt University Medical Center Phase 1 2007-04-01 The investigators propose to test the hypothesis that the sympathetic nervous system contributes to the cardiovascular and inflammatory abnormalities present in the chronic fatigue syndrome (CFS) and, in particular in the subset of patients characterized by postural tachycardia syndrome (POTS). CFS and POTS are seen mostly in otherwise normal young women, and are the cause of significant disability. A substantial proportion of patients referred for evaluation of POTS met diagnostic criteria for CFS and, conversely, a subset of patients referred for treatment for CFS have POTS. The investigators hypothesize that sympathetic activation underlies the pathophysiology of patients in whom CFS and POTS overlap (CFS-P).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Aldomet

Condition Name

Condition Name for Aldomet
Intervention Trials
Pre-Eclampsia 2
Orthostatic Intolerance 2
Postural Tachycardia Syndrome 1
Autonomic Nervous System Diseases 1
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Condition MeSH

Condition MeSH for Aldomet
Intervention Trials
Pre-Eclampsia 4
Hypertension, Pregnancy-Induced 3
Eclampsia 3
Hypertension 2
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Clinical Trial Locations for Aldomet

Trials by Country

Trials by Country for Aldomet
Location Trials
United States 4
Brazil 2
India 1
Netherlands 1
Mozambique 1
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Trials by US State

Trials by US State for Aldomet
Location Trials
Tennessee 2
Colorado 1
California 1
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Clinical Trial Progress for Aldomet

Clinical Trial Phase

Clinical Trial Phase for Aldomet
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Aldomet
Clinical Trial Phase Trials
Completed 4
Withdrawn 2
Recruiting 1
[disabled in preview] 1
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Clinical Trial Sponsors for Aldomet

Sponsor Name

Sponsor Name for Aldomet
Sponsor Trials
Vanderbilt University 2
Vanderbilt University Medical Center 2
Bill and Melinda Gates Foundation 1
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Sponsor Type

Sponsor Type for Aldomet
Sponsor Trials
Other 17
NIH 1
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Alpha Methyldopa (Aldomet): Clinical Trials, Market Analysis, and Projections

Introduction to Alpha Methyldopa (Aldomet)

Alpha methyldopa, commonly known by its brand name Aldomet, is a medication primarily used to manage high blood pressure (hypertension) and certain conditions during pregnancy, such as preeclampsia. It works by affecting the central nervous system, lowering blood pressure, and reducing chemicals in the body that narrow blood vessels.

Historical Context and Clinical Trials

Alpha methyldopa was first approved by the Food and Drug Administration (FDA) in late 1962, with commercial availability starting in January 1963[1][4].

Initially, the drug was under extensive clinical trials, and its use was recommended only for investigational purposes. However, by the time of its commercial release, it had already been established as a viable treatment for hypertension. The authors of a paper presented at the June AMA meeting in 1963 corrected their earlier statement to reflect its approved status for general use[1].

Current Clinical Use

Aldomet is prescribed for high blood pressure and hypertensive emergencies. It is also used in pregnancy to manage conditions like preeclampsia. The medication is available in oral and intravenous forms, each with specific applications and dosages[2][4].

Applications and Dosage Forms

  • Oral: Commonly used for long-term management of hypertension.
  • Intravenous Drip: Used in acute hypertensive emergencies or when oral administration is not feasible[5].

Market Analysis

The global alpha methyldopa market has been experiencing robust growth driven by several key factors.

Market Size and Growth

As of 2024, the global alpha methyldopa market was valued at $10.24 billion, up from $9.31 billion in 2023, with a compound annual growth rate (CAGR) of 10.0%. The market is projected to reach $15.14 billion by 2028 at a CAGR of 10.3%[2][5].

Growth Drivers

  • Rising Hypertension Awareness: Increasing public health campaigns and improving diagnostic techniques have led to better detection and management of hypertension.
  • Chronic Disease Management: Focus on managing chronic diseases, including hypertension, has driven the demand for alpha methyldopa.
  • Generic Versions: The availability of generic versions of alpha methyldopa has made the medication more accessible and affordable.
  • Aging Population and Obesity: The growing geriatric population and rising obesity rates have contributed to the increasing prevalence of hypertension, thereby boosting the demand for alpha methyldopa[2][5].

Regional Insights

  • North America: This region is the largest market for alpha methyldopa, driven by advanced technology adoption and the presence of major industry players.
  • Asia-Pacific: This region is also expected to experience significant growth due to increasing healthcare infrastructure and public health initiatives.
  • Europe: Europe is another key region with a strong growth trajectory, driven by advancements in healthcare and increasing healthcare expenditure[2][3].

Impact of Technological Advancements

Artificial Intelligence and Automation

The alpha methyldopa market is being transformed by artificial intelligence (AI) and automation. AI-driven analytics are enhancing drug development processes, optimizing clinical trials, and enabling personalized medicine approaches. Automation in manufacturing and quality control is contributing to cost reduction and consistent product quality, making alpha methyldopa more accessible and efficient[3].

Digital Health Solutions

Digital health solutions are also playing a crucial role in the market by improving patient monitoring, treatment adherence, and overall healthcare outcomes. These solutions are integrated into the broader healthcare infrastructure, further boosting the demand for alpha methyldopa[5].

Market Segmentation

The alpha methyldopa market is segmented by type, purity, and application.

  • Type: Oral and intravenous forms.
  • Purity: Segmented into purity levels of 98% and 99%.
  • Application: Primarily used for hypertension, but also for conditions like Parkinsonism and hepatic coma[5].

Major Manufacturers

Key players in the alpha methyldopa market include:

  • Merck
  • ICN Pharmaceuticals
  • AA Pharma
  • Pro Doc Ltée
  • Laboratoires Confab
  • LGM Pharma[3].

Challenges and Restraints

Despite the growth, the market faces several challenges:

  • High Inflation: Economic instability can affect healthcare spending and drug prices.
  • Global Conflicts: Events like the Ukraine-Russia war can disrupt supply chains and impact market growth.
  • COVID-19 Impact: The pandemic has had a mixed impact, with some areas seeing increased healthcare spending while others faced supply chain disruptions[5].

Key Takeaways

  • Alpha methyldopa is a well-established medication for managing hypertension and certain pregnancy-related conditions.
  • The global market is projected to grow significantly, driven by increasing hypertension awareness, chronic disease management, and technological advancements.
  • North America, Asia-Pacific, and Europe are key regions driving market growth.
  • AI and automation are transforming the market by enhancing drug development, manufacturing, and patient care.

FAQs

What is alpha methyldopa used for?

Alpha methyldopa is primarily used to manage high blood pressure (hypertension) and certain conditions during pregnancy, such as preeclampsia.

What are the dosage forms of alpha methyldopa?

Alpha methyldopa is available in oral and intravenous forms.

What is the projected market size of alpha methyldopa by 2028?

The global alpha methyldopa market is projected to reach $15.14 billion by 2028 at a CAGR of 10.3%.

Which regions are leading the alpha methyldopa market?

North America, Asia-Pacific, and Europe are the leading regions in the alpha methyldopa market.

How are technological advancements impacting the alpha methyldopa market?

Technological advancements, including AI and automation, are enhancing drug development, manufacturing, and patient care, making alpha methyldopa more accessible and efficient.

Sources

  1. Heath FK. Methyldopa (Aldomet). JAMA. 1963;186(1):82. doi:10.1001/jama.1963.03710010116029
  2. Alpha Methyldopa Global Market 2024 To Reach $15.14 Billion By 2028 At Rate Of 10.3% - EINPresswire
  3. α Methyldopa Market - GitHub
  4. Aldomet Alternatives Compared - Drugs.com
  5. Alpha Methyldopa Market Report 2024 - The Business Research Company
Last updated: 2025-01-01

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