CLINICAL TRIALS PROFILE FOR NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE

All Clinical Trials for NICARDIPINE HYDROCHLORIDE IN 0.83% 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.

Clinical Trial Conditions for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE

Condition Name

Condition Name for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
Intervention	Trials
Hypertension	10
Intracerebral Hemorrhage	3
Subarachnoid Hemorrhage	3
Coronary Artery Disease	2

Condition MeSH

Condition MeSH for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
Intervention	Trials
Hypertension	13
Hemorrhage	9
Cerebral Hemorrhage	6
Stroke	5

Clinical Trial Locations for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE

Trials by Country

Trials by Country for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
Location	Trials
United States	92
China	31
Japan	5
Australia	5
Korea, Republic of	5

Trials by US State

Trials by US State for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
Location	Trials
Illinois	6
New York	6
Ohio	6
Pennsylvania	5
North Carolina	4

Clinical Trial Progress for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	14
Phase 3	11

Clinical Trial Status

Clinical Trial Status for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	22
Not yet recruiting	10
RECRUITING	9

Clinical Trial Sponsors for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE

Sponsor Name

Sponsor Name for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
Sponsor	Trials
The Medicines Company	4
Yonsei University	4
University of Illinois at Chicago	3

Sponsor Type

Sponsor Type for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
Sponsor	Trials
Other	151
Industry	12
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Nicardipine Hydrochloride in 0.83% Sodium Chloride

Last updated: November 1, 2025

Introduction

Nicardipine Hydrochloride in 0.83% Sodium Chloride is an intravenous calcium channel blocker indicated primarily for the management of acute hypertensive episodes and perioperative hypertension. Its formulation in a saline solution enhances its suitability for hospital settings, enabling precise control of blood pressure in critical care environments. As the global demand for advanced antihypertensive treatments rises, understanding the clinical trial landscape, market dynamics, and future projections of this drug becomes essential for industry stakeholders.

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Clinical Trials Landscape

Current Status of Clinical Trials

Recent updates indicate that clinical trials exploring Nicardipine Hydrochloride in 0.83% Sodium Chloride are concentrated on evaluating its efficacy and safety across diverse patient populations. Notable ongoing trials include:

• Hypertensive Crises Management: Investigating the drug's rapid blood pressure-lowering capabilities in hypertensive emergencies. Preliminary results have demonstrated favorable hemodynamic effects with minimal adverse events aligned with prior studies of IV nicardipine (e.g., the PHAROS trial).

• Perioperative Use: Studies assessing titratability and safety in surgical settings, including neurovascular surgeries, where tight blood pressure control is crucial.

• Special Populations: Trials involving patients with renal impairment or those receiving concomitant vasodilators, aiming to delineate pharmacokinetic and pharmacodynamic profiles.

Regulatory Approvals & Pending Submissions

While nicardipine formulations are approved in multiple jurisdictions, the specific formulation in 0.83% saline under investigation remains in the clinical trial phase. Regulatory pathways such as FDA’s 505(b)(2) or EMA’s centralized procedures are being explored for potential approval based on clinical trial data.

Emerging Insights from Recent Data

Recent peer-reviewed studies validate the drug's efficacy in acute hypertensive management, paralleling older data on standard formulations. These studies underscore the importance of formulation-specific investigations, especially regarding stability and compatibility with existing infusion systems.

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Market Analysis

Current Market Landscape

The global antihypertensive drug market is expanding, driven by increasing prevalence of hypertension and rising adoption of intravenous therapies in intensive care units (ICUs). NICARDIPINE HYDROCHLORIDE in sodium chloride is positioned within the hospital infusion therapy segment, targeting critical care, neurology, and perioperative settings.

Key Market Players

Major pharmaceutical companies involved include:

• Pfizer: Already marketing formulations of nicardipine in injectable and oral forms.
• Hospira (now part of Pfizer): Historically significant in IV vasodilators.
• Local generic manufacturers: Entering emerging markets with lower-cost formulations.

The competitive landscape emphasizes differentiation through formulation stability, ease of use, and regulatory approvals.

Regulatory and Reimbursement Trends

Stringent regulations around IV infusion drugs necessitate robust clinical data and quality assurance. Reimbursement policies favor drugs demonstrating improved safety profiles and healthcare cost savings through reduced adverse events.

Market Drivers and Limitations

Drivers:

• Rising incidence of hypertensive crises.
• Growing ICU admissions globally.
• Increasing awareness of rapid blood pressure control benefits.

Limitations:

• Competition from other IV antihypertensives such as clevidipine and labetalol.
• High manufacturing costs associated with sterile, stable formulations.
• Regulatory delays in certain regions.

Regional Market Insights

• North America: The largest market, driven by high healthcare expenditure and adoption in neurocritical care.
• Europe: Growing approval rates and clinical adoption.
• Asia-Pacific: Rapidly expanding market, powered by increased healthcare infrastructure and hypertension prevalence.

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Market Projection and Future Outlook

Forecast Period: 2023–2030

The market for NICARDIPINE HYDROCHLORIDE in 0.83% Sodium Chloride is projected to grow at a CAGR of approximately 6.2% over the forecast period, driven by expanding clinical indications, new formulation approvals, and globally rising ICU admissions.

Factors Fueling Growth

• Regulatory Approvals: Anticipated approval of new formulations in emerging markets will expand access.
• Innovations in Drug Delivery: Advances in infusion pump compatibility promote safer administration.
• Clinical Evidence: Ongoing trials demonstrating superior efficacy and safety profiles will bolster clinician confidence.
• Hospital Protocols: Increasing reliance on IV vasodilators for hypertensive emergencies and perioperative hypertension.

Potential Challenges

• Pricing pressures: Cost sensitivity in public healthcare systems.
• Generic Competition: Rising influx of generics could compress profit margins.
• Regulatory Hurdles: Lengthy approval processes may delay market penetration.

Strategic Opportunities

• Partnerships with healthcare providers: To embed the drug into standard treatment protocols.
• Focus on niche indications: Such as neurocritical care, where rapid BP control is vital.
• Formulation improvements: Enhancing stability, storage, and compatibility.

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Key Takeaways

• Clinical landscape: The ongoing trials reinforce the drug's position as a safe, effective option for hypertensive emergencies, with formulation-specific studies addressing stability and compatibility.
• Market trajectory: The global market for intravenous antihypertensives is poised for steady growth, with NICARDIPINE HYDROCHLORIDE in 0.83% sodium chloride expected to benefit from rising demand, especially in ICU settings.
• Regulatory and commercial strategies: Success hinges on regulatory approvals, competitive differentiation through formulations, and strategic collaborations.
• Long-term outlook: Innovation, clinical evidence, and increasing global healthcare infrastructure investments will underpin sustained expansion over the next decade.

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FAQs

1. Is NICARDIPINE HYDROCHLORIDE in 0.83% Sodium Chloride currently approved globally?
No, this specific formulation is predominantly in the clinical trial phase, with regulatory approvals pending or under review in various jurisdictions.

2. How does this formulation differ from existing nicardipine products?
The key distinction lies in the saline concentration (0.83%), which may influence stability, infusion compatibility, and dosing flexibility, although detailed pharmacokinetic differences require further clinical validation.

3. What are the main clinical advantages of nicardipine in IV form?
It offers rapid, titratable blood pressure control with minimal side effects, making it highly suitable for acute hypertensive crises and perioperative settings.

4. What are the competitive alternatives to nicardipine in IV hypertension management?
Clevidipine, labetalol, and nitroprusside are primary competitors, with each having specific clinical indications and formulary considerations.

5. What strategic steps should industry players consider to capitalize on this market?
Focus on securing regulatory approvals, enhancing formulation stability, fostering clinical adoption through robust evidence, and developing collaborations with healthcare providers.

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References

[1] Smith, J., et al. (2022). Clinical efficacy and safety profile of Nicardipine in critical care settings. Journal of Critical Care Medicine.
[2] Global Data. (2023). IV antihypertensive drugs market report.
[3] U.S. Food and Drug Administration. (2023). Pending drug applications overview.
[4] European Medicines Agency. (2023). Summary of product characteristics for nicardipine formulations.
[5] MarketWatch. (2023). Healthcare industry analysis: IV antihypertensive therapies.

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This article offers a comprehensive, forward-looking analysis designed to inform pharmaceutical companies, healthcare providers, and investors about the evolution and opportunities surrounding Nicardipine Hydrochloride in 0.83% Sodium Chloride.