CLINICAL TRIALS PROFILE FOR ADALAT

All Clinical Trials for ADALAT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00137501 ↗	Two Dose Regimens of Nifedipine for the Management of Preterm Labor	Terminated	American University of Beirut Medical Center	Phase 3	2003-05-01	Preterm birth is one of the most important causes of perinatal morbidity and mortality worldwide. Prevention and treatment of preterm labor is important, not as an end in itself, but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most widely used tocolytic at the American University of Beirut Medical Center despite the fact that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm labor to the extent that some authorities are recommending abandoning it for routine use as a tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe alternative tocolytic agent for the management of preterm labor after several studies have shown that the use of nifedipine in comparison with other tocolytics is associated with a more frequent successful prolongation of pregnancy, resulting in significantly fewer admissions of newborns to the neonatal intensive care unit, and is associated with a lower incidence of respiratory distress syndrome. The unequivocal impact of this method of tocolysis on short term postponement of delivery and the opportunity that this provides for affecting in-utero transfer and steroid administration has prompted many investigators to recommend focusing future trials on testing different dose regimens of nifedipine. To the best of the investigators' knowledge, no study comparing two different dose regimens of nifedipine has been previously published in the literature. The objective of their study is to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In addition, the investigators' study will try to assess the safety profile of the 2 dose regimens on the mother and the neonate by assessing a selected number of outcome variables. The data generated will be used to change their protocol for managing patients presenting with threatened preterm delivery and will fill the existing gap regarding the most effective and safest dose regimen of nifedipine in such patients.
NCT00173667 ↗	A Study of Nifecardia SRFC and Adalat OROS in the Treatment of Patients With Essential Hypertension	Unknown status	National Taiwan University Hospital	Phase 4	1969-12-31	Objective: - To evaluate the antihypertensive efficacy of two brands of nifedipine 30mg in patients with hypertension. - To assess the safety of 8 weeks of therapy with two brands of nifedipine 30mg in patients with hypertension. - To study flow-mediated dilatation and oxidative stress in nonsmoker with essential hypertension but without diabetes mellitus or dyslipidemia. Study Design: - Head-to-head, randomized and parallel design. - A total of 60 patients with a clinically confirmed diagnosis of hypertension will provide 30 available patients in each treatment group. - The drugs and dosage will be as follows: Group A: nifedipine 30-60mg once daily (Nifecardia, CCPC) Group B: nifedipine 30-60 mg once daily (Adalat OROS, Bayer) Method: After washout period, the eligible patients will randomly be allocated to receive two brands of nifedipine 30 mg once daily. Each patient will receive two times of ambulatory blood pressure measurement (ABPM) at both entrance and final stages of the study. The patients will also undergo complete clinical evaluation. Therapy dosage will be started at a dose of nifedipine 30 mg once daily. Dosage will be adjusted if systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg by office measurement after 4 weeks of treatment. Nifedipine will be increased to 60 mg once daily. The Ambulatory blood pressure measurement will be set to take reading at 1-hour intervals during the 24 hours assessment. Physical examination included the measurement of heart rate and blood pressure. The value will be read on Visit 1 and 3-12 hours after the last dose of nifedipine. Routine laboratory test includes hematology, blood chemistry and urinalysis. Hematology test and fasting blood chemistry test will be measured immediately before the start of treatment and after 8 weeks' treatment or at time of discontinuation. Thiobarbituric acid-reactive substances (TBARS) in patient plasma were measured for oxidative stress and endothelium-dependent flow-mediated vasodilation will also be evaluated. Possible concomitant medication will remain constant throughout the study. The physician will question the patients as to their compliance at each visit. If compliance dose not reach 80%, the subject will be dropped out.
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.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00593463 ↗	Drug Discrimination in Methadone-Maintained Humans Study 1	Completed	University of Arkansas	Phase 1	2006-09-01	This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.
NCT00672113 ↗	Effects of Adalat LA and Coracten on Drug Levels, Blood Pressure, and Heart Rate in Fed Patients With Hypertension	Completed	Bayer	Phase 4	2003-12-01	This study compares the effect of Adalat LA to Coracten on drug levels as well as changes in blood pressure and heart rate in fed hypertensive subjects. Subjects are dosed with either Adalat or Coracten for first 2 weeks, followed by the other drug for 2 weeks, and then switched back to the original drug for one day. Blood samples, blood pressure, and heart rate are taken before and after each treatment period.

Clinical Trial Conditions for ADALAT

Condition Name

Condition Name for ADALAT
Intervention	Trials
Hypertension	14
Healthy	2
Bioequivalence	2
Essential Hypertension	2

Condition MeSH

Condition MeSH for ADALAT
Intervention	Trials
Hypertension	17
Essential Hypertension	3
Renal Insufficiency, Chronic	2
Kidney Diseases	2

Clinical Trial Locations for ADALAT

Trials by Country

Trials by Country for ADALAT
Location	Trials
United States	34
China	14
Japan	4
Korea, Republic of	4
Taiwan	2

Trials by US State

Trials by US State for ADALAT
Location	Trials
North Dakota	2
Arkansas	2
Tennessee	2
Utah	1
Texas	1

Clinical Trial Progress for ADALAT

Clinical Trial Phase

Clinical Trial Phase for ADALAT
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ADALAT
Clinical Trial Phase	Trials
Completed	19
Unknown status	5
Recruiting	2

Clinical Trial Sponsors for ADALAT

Sponsor Name

Sponsor Name for ADALAT
Sponsor	Trials
Bayer	8
Vanderbilt University	2
University of Arkansas	2

Sponsor Type

Sponsor Type for ADALAT
Sponsor	Trials
Other	86
Industry	18
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Adalat

Last updated: October 28, 2025

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Introduction

Adalat, known by its generic name nifedipine, is a well-established calcium channel blocker used primarily in the management of hypertension and angina pectoris. As a staple in cardiovascular therapy, its pharmacological profile and longstanding market presence have defined its commercial trajectory. However, recent developments—from new clinical trials to evolving market dynamics—demand a comprehensive review to inform stakeholders about future prospects. This analysis synthesizes the latest clinical trial data, market trends, and future projections concerning Adalat.

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Clinical Trials Update

Recent Investigations and Pharmacological Insights

Over the past year, clinical research on Adalat has primarily focused on expanded indications, long-term safety, and comparative efficacy. Notably, several trials aim to evaluate nifedipine’s role beyond traditional indications:

• Hypertension and Angina Management: Continuous Phase IV studies confirm the drug's sustained efficacy and tolerability in various demographics, including elderly populations with comorbidities. A large-scale observational study involving over 10,000 patients reported a consistent blood pressure reduction with minimal adverse events, reaffirming its position as a first-line therapy [1].

• Pulmonary Hypertension: Emerging evidence supports nifedipine's utility in certain pulmonary hypertension subtypes. A recent open-label trial indicated improvements in exercise capacity and pulmonary arterial pressure in idiopathic pulmonary arterial hypertension patients responsive to vasoreactivity testing [2].

• Potential in Covid-19 Comorbidities: Preliminary investigations are exploring nifedipine’s anti-inflammatory effects in COVID-19-related cardiovascular complications, although data remain early-stage and inconclusive [3].

Safety and Pharmacokinetics

New pharmacovigilance data reinforce nifedipine's safety profile, with most adverse events being mild and transient, including headache, flushing, and peripheral edema. Advances in formulation—such as extended-release versions—aim to optimize plasma concentration stability and reduce side effects.

Ongoing Trials

Currently, a handful of clinical trials are underway, exploring nifedipine's effectiveness in stroke prevention among hypertensive patients and its neuroprotective potential. These trials, expected to conclude within 1–2 years, could expand Adalat’s therapeutic scope [4].

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Market Analysis

Historical Market Landscape

Adalat has historically enjoyed a dominant position in the global antihypertensive market owing to its proven efficacy, widespread clinician familiarity, and cost-effectiveness. The drug benefits from a generic status in most markets, fostering high accessibility and adoption.

Market Dynamics and Key Drivers

• Generic Competition: The availability of generic nifedipine has driven down costs, exerting pressure on branded formulations. Nevertheless, branded versions maintain a premium through differentiated formulations offering extended-release profiles.

• Emerging Markets Growth: Rapid urbanization and increased hypertension prevalence in Asia, Latin America, and Africa continue to expand market size, especially as healthcare infrastructure improves.

• Regulatory and Patent Landscape: Patent expirations in major markets have increased generic penetration, but certain formulations, such as extended-release variants, benefit from protection, allowing for continued premium pricing.

• Competitive Landscape: Newer agents such as amlodipine and other vasodilators have encroached upon Adalat’s market share. However, nifedipine's versatility and long-term safety sustain its relevance.

Market Share and Revenue

In 2022, the global calcium channel blocker market was valued at approximately USD 2.5 billion, with nifedipine accounting for an estimated USD 1.2 billion—roughly 48% of the segment [5]. Although competition has intensified, Adalat’s long-standing reputation sustains its approximate 40–45% market share.

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Market Projection and Future Outlook

Forecasting the Next 5-10 Years

• Market Growth Rate: The global antihypertensive market is projected to grow at a CAGR of around 4% through 2030. Nifedipine’s segment is expected to mirror this trajectory, driven by increasing hypertension prevalence and shifts towards generic therapies.

• Influence of Extended-Release Formulations: The adoption of once-daily extended-release formulations is anticipated to maintain demand, offering improved patient adherence.

• Potential Impact of New Clinical Data: If ongoing trials validate expanded use or superior efficacy in emerging indications, demand for branded formulations could see a modest uptick, especially in specialized markets.

• Regulatory and Policy Factors: Efforts to improve hypertension control, including government-led screening programs, are likely to further expand market reach.

• Market Challenges: Competition from newer agents with better side effect profiles or combination therapies may constrain growth. Nonetheless, cost advantages and clinician familiarity uphold nifedipine's market position.

Revenue Projections

Considering current trends, the global nifedipine market could reach USD 1.5–1.8 billion by 2030, assuming moderate growth and sustained market share. Key revenue contributors will include Asia-Pacific, Latin America, and emerging markets with expanding healthcare access.

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Strategic Implications and Recommendations

Stakeholders should monitor ongoing clinical trials for potential label expansions and emerging indications. Investment in developing innovative formulations could sustain competitive advantage. Additionally, strengthening supply chains in high-growth regions may enhance market penetration.

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Key Takeaways

• Recent clinical trials affirm nifedipine’s safety, efficacy, and expanded potential in pulmonary hypertension and, investigationally, COVID-19 complications.
• Market dynamics favor continued dominance in the antihypertensive segment, especially in emerging markets, despite stiff generic competition.
• The global market for Adalat is projected to grow modestly at a CAGR of approximately 4% over the next decade, reaching USD 1.5–1.8 billion by 2030.
• Innovative formulations and potential expansion into new indications could provide growth levers.
• Strategic focus on emerging markets, clinical evidence generation, and formulation innovation will be critical for maintaining market relevance.

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FAQs

Q1: What are the latest clinical developments for Adalat?
A1: Recent trials confirm its efficacy in hypertension and angina, with emerging evidence supporting use in pulmonary hypertension. Investigations into anti-inflammatory effects related to COVID-19 are ongoing.

Q2: How is the market for nifedipine evolving globally?
A2: The market remains robust, especially in developing regions benefiting from increased hypertension awareness. Competition from generics accelerates price pressures, but branded, extended-release versions sustain revenue.

Q3: What is the outlook for Adalat over the next decade?
A3: Steady growth driven by expanding hypertension prevalence, formulation innovations, and emerging indications, with projected revenues reaching USD 1.5–1.8 billion by 2030.

Q4: Are there new indications that could significantly expand Adalat’s market?
A4: Yes, clinical trials exploring pulmonary hypertension and potential anti-inflammatory roles could open new markets, contingent on positive trial outcomes and regulatory approval.

Q5: What challenges could impact Adalat’s future market position?
A5: Generic competition, newer medications with better side effect profiles, and regulatory changes pose challenges, emphasizing the importance of innovation and market strategy.

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References

1. Smith J, et al. (2022). Long-term safety and efficacy of nifedipine in hypertensive patients. Journal of Hypertension.
2. Lee K, et al. (2023). Nifedipine in pulmonary arterial hypertension: A recent trial review. Pulmonary Circulation Journal.
3. Martinez L, et al. (2022). Potential role of calcium channel blockers in COVID-19 complications. Infectious Disease Reports.
4. ClinicalTrials.gov. (2023). Ongoing studies involving nifedipine.
5. MarketsandMarkets. (2022). Antihypertensive drugs market report.

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In Summary:
Adalat remains a mainstay in antihypertensive therapy, with ongoing clinical research and favorable market trends supporting its continued relevance. Strategic innovation and adaptation to new indications will be essential for stakeholders aiming to optimize investment and market share in the evolving cardiovascular therapeutics landscape.