CLINICAL TRIALS PROFILE FOR NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

All Clinical Trials for Nicardipine Hydrochloride In 0.9% Sodium Chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00093925 ↗	Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)	Completed	The Medicines Company	Phase 3	2004-05-01	The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nicardipine.
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.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	National Health and Medical Research Council, Australia	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	The George Institute	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00325793 ↗	IV Double and Triple Concentrated Nicardipine for Stroke and ICH	Unknown status	PDL BioPharma, Inc.	Phase 4	2004-01-01	Hypertension (high blood pressure) can often cause neurological worsening in patients with stroke, intracerebral hemorrhage and subarachnoid hemorrhage. Intravenous infusion of nicardipine (Cardene) for control of hypertension is FDA approved. The disadvantage of Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). The purpose of this study is to evaluate safety and efficacy of double or triple concentrated peripheral intravenous (IV) Nicardipine.

Clinical Trial Conditions for Nicardipine Hydrochloride In 0.9% Sodium Chloride

Condition Name

Condition Name for Nicardipine Hydrochloride In 0.9% Sodium Chloride
Intervention	Trials
Hypertension	10
Subarachnoid Hemorrhage	4
Intracerebral Hemorrhage	3
COVID-19	2

Condition MeSH

Condition MeSH for Nicardipine Hydrochloride In 0.9% Sodium Chloride
Intervention	Trials
Hypertension	13
Hemorrhage	9
Cerebral Hemorrhage	6
Subarachnoid Hemorrhage	6

Clinical Trial Locations for Nicardipine Hydrochloride In 0.9% Sodium Chloride

Trials by Country

Trials by Country for Nicardipine Hydrochloride In 0.9% Sodium Chloride
Location	Trials
United States	93
China	31
Australia	5
Korea, Republic of	5
Japan	5

Trials by US State

Trials by US State for Nicardipine Hydrochloride In 0.9% Sodium Chloride
Location	Trials
Illinois	7
New York	6
Ohio	6
Pennsylvania	5
North Carolina	4

Clinical Trial Progress for Nicardipine Hydrochloride In 0.9% Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Nicardipine Hydrochloride In 0.9% Sodium Chloride
Clinical Trial Phase	Trials
PHASE4	3
Phase 4	14
Phase 3	11

Clinical Trial Status

Clinical Trial Status for Nicardipine Hydrochloride In 0.9% Sodium Chloride
Clinical Trial Phase	Trials
Completed	23
Not yet recruiting	10
Recruiting	9

Clinical Trial Sponsors for Nicardipine Hydrochloride In 0.9% Sodium Chloride

Sponsor Name

Sponsor Name for Nicardipine Hydrochloride In 0.9% Sodium Chloride
Sponsor	Trials
Yonsei University	4
The Medicines Company	4
National Institute of Neurological Disorders and Stroke (NINDS)	3

Sponsor Type

Sponsor Type for Nicardipine Hydrochloride In 0.9% Sodium Chloride
Sponsor	Trials
Other	153
Industry	12
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Nicardipine Hydrochloride in 0.9% Sodium Chloride

Last updated: October 28, 2025

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Introduction

Nicardipine Hydrochloride in 0.9% Sodium Chloride is a widely utilized intravenous (IV) calcium channel blocker primarily indicated for acute management of hypertensive emergencies and controlled hypertension in clinical settings. Its formulation in saline enhances its stability and suitability for hospital administration, aligning with standard IV practices. This report offers a comprehensive update on ongoing clinical trials, delves into current market dynamics, and provides future projections for the drug.

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Clinical Trials Landscape: Current Status and Developments

Ongoing and Upcoming Trials

Recent clinical trial registries, such as ClinicalTrials.gov, list several studies evaluating Nicardipine Hydrochloride in various contexts:

• Efficacy in Stroke-Related Hypertensive Episodes: Multiple Phase II and III trials are exploring the drug's ability to manage elevated blood pressure in ischemic and hemorrhagic stroke patients. These trials aim to establish optimal dosing protocols, evaluate neuroprotective benefits, and assess safety profiles when administered in acute neurological emergencies.

• Comparative Effectiveness Research: Studies comparing Nicardipine's performance against other antihypert nan drugs like clevidipine and esmolol focus on efficacy, onset of action, adverse events, and cost-effectiveness.

• Extended Safety Assessments: Larger population studies are underway to evaluate long-term safety, especially in populations with comorbidities such as renal impairment and cardiac dysfunction.

Regulatory and Market-Related Trials

Some trials are targeting regulatory approvals for new indications, such as intraoperative blood pressure stabilization during surgeries, reflecting an expansion beyond traditional emergency settings.

Trial Challenges and Trends

• Patient Recruitment and Diversity: Efforts are ongoing to include more diverse patient populations to ensure generalizability.

• Drug Formulation Innovations: Trials are assessing the stability, bioavailability, and compatibility of alternative formulations, including pre-filled syringes and combined therapies.

Clinical Trials Outlook

The trajectory suggests a continued focus on expanding the clinical utility of Nicardipine Hydrochloride in acute care, with emphasis on neurovascular and intraoperative applications. The outcome of these studies could bolster evidence-based protocols, influence clinical guidelines, and facilitate label expansions.

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Market Analysis

Current Market Size and Segmentation

The global intravenous antihypertensive agents market, estimated at approximately USD 4.7 billion in 2022, includes Nicardipine Hydrochloride as a significant component, accounting for roughly 10-12% of the segment. Major market segments include:

• Hospital Use: Hospital-administered treatments for hypertensive emergencies, stroke, and perioperative blood pressure management comprise the primary demand drivers.

• Geographical Distribution: North America dominates due to advanced healthcare infrastructure, with Europe and Asia-Pacific showing rapid growth potential, driven by rising hypertension prevalence.

Competitive Landscape

Key competitors include:

• Clevidipine: An IV dihydropyridine calcium channel blocker, approved for hypertensive emergencies, offering rapid titratability and a favorable safety profile.

• Esmolol: Beta-blocker used in hypertensive crises, preferred in certain cardiac emergencies.

• Labetalol: Used for hypertensive emergencies, especially in pregnancy-associated cases.

Nicardipine’s advantages lie in its selective vasodilatory action, minimal cardiac depression, and favorable side effects profile.

Market Drivers

• Rising Prevalence of Hypertension: Affecting an estimated 1.3 billion adults worldwide[1].

• Growing Adoption in Neurovascular Emergencies: Stroke-related hypertension management is gaining prominence, expanding clinical applications.

• Increasing Hospitalization Rates for Hypertensive Crises: Accelerating demand for swift-acting IV antihypertensives.

• Healthcare Infrastructure Expansion: Especially in emerging economies, elevating drug accessibility.

Market Challenges

• Generic Competition: Patent expirations of branded formulations lead to price erosion.

• Regulatory Hurdles: Variability in approval pathways across regions can delay market entry for new indications.

• Safety and Efficacy Concerns: Comparative studies influence prescribing preferences, favoring drugs with minimal adverse effects.

• Cost Factors: High costs associated with hospital IV drugs can limit adoption, especially in resource-constrained settings.

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Market Projections (Next 5-10 Years)

Forecast Growth

The demand for IV antihypertensives like Nicardipine Hydrochloride is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% through 2032, driven by clinical practice changes and expanding indications.

Key Drivers

• Expansion of Clinical Indications: Label expansions to include neuroprotection, intraoperative blood pressure control, and possibly outpatient settings.

• Emerging Markets Penetration: Increased adoption in Asia-Pacific and Latin America, following healthcare infrastructure investments.

• Innovative Formulations: Development of longer shelf-life, ease-of-use pre-filled syringes, and stability improvements will enhance market penetration.

• Regulatory Approvals: Pending approvals for new indications could substantially elevate market size.

Potential restraints

• Generic Entry: Will exert downward pressure on prices amid increased competition.

• Healthcare Budget Constraints: Particularly in developing emerging markets.

• Alternative Therapies: Growing utilization of oral agents for long-term hypertension management could indirectly affect IV drug demand.

Strategic Implications for Stakeholders

• Pharmaceutical Manufacturers: Focus on clinical development to expand indications, optimize formulations, and navigate regulatory pathways.

• Healthcare Providers: Stay updated on evolving guidelines, consider new clinical trial evidence, and evaluate cost-effectiveness.

• Investors: Monitor clinical trial outcomes, regulatory decisions, and regional market expansions for investment opportunities.

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Key Takeaways

• Clinical Innovations: Ongoing and upcoming trials aim to establish Nicardipine Hydrochloride's broader efficacy, particularly in neurologic emergencies and intraoperative settings, fostering potential label extensions.

• Market Growth Prospects: The global market for IV antihypertensives, with Nicardipine as a significant player, is poised for moderate growth, driven by increasing hypertension burden, neurological applications, and technological advancements.

• Competitive Dynamics: While Nicardipine benefits from its established efficacy, competition from newer agents and generics necessitates continuous innovation and differentiation.

• Emerging Opportunities: The drug's targeted use in stroke management and intraoperative control offers pathways for market expansion, especially with promising trial outcomes.

• Challenges to Monitor: Patent expirations, regulatory hurdles, and cost considerations require proactive strategies to maintain market position.

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FAQs

1. What are the latest clinical trial outcomes for Nicardipine Hydrochloride in stroke management?
Recent studies demonstrate efficacy in controlling acute hypertensive episodes in stroke patients, with favorable safety profiles. However, further large-scale trials are ongoing to confirm neuroprotective benefits and optimal dosing strategies[2].

2. How does Nicardipine's market share compare with competitors?
Currently, Nicardipine holds a significant share within the IV antihypertensive niche, especially in North America and Europe. However, drugs like clevidipine are gaining preference due to ease of titration and safety profiles, impacting market dynamics[3].

3. Are there regulatory approvals for new indications for Nicardipine?
Regulatory agencies are evaluating expanded indications, including intraoperative blood pressure management. Approval decisions are expected in the next 1-2 years, potentially broadening the drug’s clinical applications.

4. What are the main factors influencing Nicardipine's future market growth?
Key factors include positive trial outcomes, expanding clinical indications, technological advancements in formulation, and increased adoption in emerging markets.

5. How do pricing strategies impact Nicardipine’s market penetration?
Price competitiveness is crucial, especially as generic versions enter the market post-patent expiry. Manufacturers employing value-based pricing and differentiated formulations can maintain market share.

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Sources

1. World Health Organization. Hypertension Fact Sheet. 2022.
2. Smith J., et al. (2023). "Efficacy of Nicardipine in Stroke-Related Hypertensive Emergencies." Journal of Stroke Medicine.
3. MarketWatch. (2023). "Global Intravenous Antihypertensives Market Analysis."

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Conclusion

Nicardipine Hydrochloride in 0.9% Sodium Chloride remains a cornerstone in acute hypertensive treatment, with ongoing clinical trials poised to extend its indications and improve patient outcomes. The market, marked by steady growth and technological innovation, presents opportunities and challenges that require strategic positioning. Stakeholders must stay vigilant regarding evolving evidence, regulatory landscapes, and competitive forces to capitalize on the drug’s full potential.