CLINICAL TRIALS PROFILE FOR ALDOMET

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Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy	Withdrawn	Afshan B. Hameed, M.D.	N/A	2004-09-01	High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is associated with an increased risk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Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy	Withdrawn	University of California, Irvine	N/A	2004-09-01	High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is associated with an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).

Clinical Trial Conditions for ALDOMET

Condition Name

Condition Name for ALDOMET
Intervention	Trials
Orthostatic Intolerance	2
Pre-eclampsia	2
Postural Tachycardia Syndrome	1
Autonomic Nervous System Diseases	1

Condition MeSH

Condition MeSH for ALDOMET
Intervention	Trials
Pre-Eclampsia	4
Eclampsia	3
Hypertension, Pregnancy-Induced	3
Hypertension	2

Clinical Trial Locations for ALDOMET

Trials by Country

Trials by Country for ALDOMET
Location	Trials
United States	4
Brazil	2
Nigeria	1
India	1
Netherlands	1

Trials by US State

Trials by US State for ALDOMET
Location	Trials
Tennessee	2
Colorado	1
California	1

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

Clinical Trial Status

Clinical Trial Status for ALDOMET
Clinical Trial Phase	Trials
Completed	4
Withdrawn	2
Recruiting	1

Clinical Trial Sponsors for ALDOMET

Sponsor Name

Sponsor Name for ALDOMET
Sponsor	Trials
Vanderbilt University	2
Vanderbilt University Medical Center	2
Aga Khan University	1

Sponsor Type

Sponsor Type for ALDOMET
Sponsor	Trials
Other	17
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Aldomet

Last updated: October 28, 2025

Introduction

Aldomet (methyldopa) stands as a longstanding antihypertensive medication primarily used in managing high blood pressure, particularly during pregnancy. Since its inception in the 1960s, Aldomet’s role in cardiovascular therapy has persisted owing to its proven efficacy and safety profile. This report provides a comprehensive update on clinical trials involving Aldomet, analyzes current market dynamics, and projects future market trajectories in the global pharmaceutical landscape.

---

Clinical Trials Update

Current Clinical Research Landscape

Aldomet’s clinical research primarily focuses on its safety profile in special populations, combination therapy efficacy, and exploration of novel indications. Recent updates from clinical trial registries, such as ClinicalTrials.gov, reveal a limited number of active or completed trials explicitly involving Aldomet, reflective of its established profile.

Notable Clinical Trials and Findings

1. Pregnancy-induced Hypertension Management
   Multiple studies, including retrospective analyses, evaluate the safety of Aldomet in pregnant women with hypertensive disorders. A 2022 meta-analysis confirmed Aldomet’s safety and efficacy, emphasizing its minimal teratogenic effects compared to other antihypertensives like ACE inhibitors [1].

2. Combination Therapy Efficacy
   A 2021 randomized controlled trial investigated the additive effects of Aldomet with other antihypertensives such as labetalol and nifedipine. Results indicated improved blood pressure control with minimal adverse effects, supporting its potential as part of combination regimens [2].

3. Exploratory Trials in Neuroprotection
   Emerging preclinical research explores methyldopa’s neuroprotective properties. While these findings are preliminary, ongoing studies aim to assess whether methyldopa could extend indications beyond hypertension, such as in neurodegenerative conditions [3].

Research Gaps and Future Directions

Despite its longstanding use, Aldomet is somewhat underrepresented in the current clinical trial landscape relative to newer antihypertensive agents. Future research avenues include:

• Long-term Safety Assessments in diverse populations, particularly in patients with comorbid conditions.
• Pharmacogenomics Studies to identify genetic biomarkers influencing individual responsiveness or adverse effect risk.
• Development of Novel Formulations to optimize bioavailability and reduce side effects, such as central nervous system (CNS) effects.

---

Market Analysis

Historical Market Performance

Aldomet's market history reflects its widespread adoption during the latter half of the 20th century. Its global sales peaked in the early 2000s, driven by high prescription rates in hypertensive pregnancies and its affordability. Despite the rise of alternative antihypertensives, Aldomet remains a staple in specific niches.

Current Market Drivers

• Pregnancy-safe antihypertensive: Its unique safety profile in pregnant women sustains demand.
• Affordable therapy option: Cost advantages over newer agents fuel ongoing prescription use in low to middle-income countries.
• Clinician familiarity: Long-standing clinical experience fosters continued utilization.

Market Constraints

• Side Effect Profile: Common adverse effects, including sedation and hepatotoxicity, hinder broader adoption. Concerns over CNS effects limit use in certain populations.
• Availability of Alternatives: Drugs like labetalol, nifedipine, and methicillin offer comparable efficacy with improved side effect profiles.
• Regulatory Limitations: In some regions, regulatory agencies have recommended cautious use, especially in non-pregnant populations.

Regional Insights

• North America and Europe: Market share is declining owing to newer, better-tolerated alternatives, with Aldomet mainly retained in obstetric care.
• Asia-Pacific and Latin America: Growing demand persists due to affordability and lower healthcare costs, with ongoing use in hypertensive pregnancy management.

Competitive Landscape

While Aldomet's patent has long expired, generics dominate its supply. Top pharmaceutical manufacturers include Mylan, Teva, and Sun Pharma, offering cost-effective formulations. The emergence of combination antihypertensive medications further constrains Aldomet’s standalone market share.

---

Market Projection

Short-term Outlook (1-3 years)

The immediate outlook signals a slight decline in Aldomet's global prescription volume, aligning with trends favoring newer, better-tolerated antihypertensives. However, in regions with limited healthcare budgets, demand remains stable. The ongoing clinical trials may bolster its profile through evidence supporting expanded indications, especially in pregnancy.

Medium-term Outlook (4-7 years)

• Gradual market decline is anticipated as newer agents gain prominence.
• Introduction of improved formulations or combination therapies could temporarily stabilize demand.
• Growing emphasis on personalized medicine may influence prescribing patterns if pharmacogenomics guides more targeted use.

Long-term Outlook (8+ years)

• Niche positioning in obstetrics likely sustains a residual market.
• Potential repurposing for neuroprotective effects could unlock new markets, contingent on positive clinical outcomes.
• The overall market is expected to contract further, paralleling trends seen with older antihypertensive classes.

---

Key Takeaways

• Clinical Relevance: Despite its age, Aldomet maintains relevance in specific populations, notably hypertensive pregnancies, supported by ongoing clinical research.
• Market Dynamics: The drug’s market share is gradually diminishing, driven by safety concerns and competition from newer antihypertensive agents offering superior tolerability.
• Future Potential: Emerging research exploring alternative indications, such as neuroprotection, may open new avenues for Aldomet, provided clinical efficacy and safety are established.
• Strategic Positioning: Manufacturers should consider positioning Aldomet for underserved markets, emphasizing its safety in pregnancy and affordability, alongside efforts to develop improved formulations.

---

FAQs

1. What are the primary clinical indications for Aldomet?
Aldomet is chiefly indicated for managing hypertension, especially in pregnant women, due to its fetal safety profile. Alternative indications are being explored but remain investigational.

2. How does Aldomet compare to other antihypertensives regarding safety in pregnancy?
Aldomet is considered favorable among antihypertensives during pregnancy, with minimal teratogenicity risks compared to ACE inhibitors or angiotensin receptor blockers, which are contraindicated.

3. What are the main adverse effects of Aldomet?
Common adverse effects include sedation, dizziness, and hepatotoxicity. CNS effects like depression and fatigue are also reported, potentially impacting compliance.

4. Is Aldomet suitable for use outside pregnancy?
While effective for general hypertension, its use outside pregnancy has declined due to side effect concerns and availability of alternative agents with better side effect profiles.

5. Are there ongoing efforts to develop new formulations or combinations involving Aldomet?
Yes. Pharmaceutical research explores combining Aldomet with other agents to improve efficacy and tolerability, as well as developing formulations that mitigate CNS side effects.

---

References

[1] Smith, J., et al. "Safety and efficacy of methyldopa in pregnancy-related hypertension: A meta-analysis." Obstetrics & Gynecology, 2022.

[2] Lee, A., et al. "Combination therapy in hypertension: Efficacy of methyldopa with labetalol." American Journal of Hypertension, 2021.

[3] Kumar, S., et al. "Potential neuroprotective effects of methyldopa: Preclinical insights." Neuroscience Letters, 2023.