CLINICAL TRIALS PROFILE FOR CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

All Clinical Trials for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00325793 ↗	IV Double and Triple Concentrated Nicardipine for Stroke and ICH	Unknown status	OSF Healthcare System	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.
NCT00528827 ↗	A Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension	Withdrawn	Facet Biotech	Phase 2	2007-09-01	To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric subjects with hypertension.
NCT00765648 ↗	Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department	Completed	EKR Therapeutics, Inc	Phase 4	2008-10-01	The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol administered intravenously for the management of hypertension in the emergency department setting.
NCT00765648 ↗	Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department	Completed	The Cleveland Clinic	Phase 4	2008-10-01	The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol administered intravenously for the management of hypertension in the emergency department setting.
NCT01526876 ↗	The Effect of Clevidipine on Intracranial Pressure and Cerebral Perfusion Pressure (CCP) in Brain Injured Patients	Withdrawn	The Medicines Company	Phase 4	2011-11-01	Patients with acute brain injury are at risk for complications such as increased pressure in the brain (intracranial pressure (ICP)), decreased blood flow, bleeding, and brain swelling (cerebral edema). Several studies have suggested that high blood pressure is associated with a worsening outcome possibly due to an increased rate of continued bleeding or rebleeding, as well as increased brain swelling (cerebral edema). High systemic (body) blood pressure (SBP) may also increase the risk of ongoing bleeding. Therefore lowering the blood pressure (BP) is critical, as continued bleeding occurs most frequently in patients with high BP. Clevidipine Butyrate (Cleviprex) is a new medication approved by the FDA for the treatment of acute high blood pressure (hypertension). Cleviprex is given through an intravenous line (IV) and has the benefit of being faster acting and easier to control adjustments than other drugs used to treat high BP. Patients who have an acute brain injury and who have severe high BP may benefit from this faster acting medication. For this study, eligible patients, 18 yrs of age or older, will have been admitted to the Neurocritical care unit within 24 hours after their brain injury, who have high systemic (body) SBP. The treating physicians will have already had multimodality brain monitoring placed for clinical management of the patient (standard care). The investigators will use Cleviprex to lower their SBP and record brain pressure and brain blood flow measurements from the multimodality monitoring. Due to the severity of their brain injury most of the patients eligible for the study will be unable to provide consent. Informed consent will be sought from a surrogate (family member, spouse or close friend) according to Columbia University Medical Center guidelines. Cleviprex is fast acting and effects are seen in about 90 seconds. The medication will be started at a low rate, and if the SBP still needs lowering, the dose increased every 90 seconds until the maximum FDA approved dose is reached. If the SBP is still high, another medication used to treat high blood pressure will be added (Cardene or labetolol). Once the SBP is lowered and is stable, the Cleviprex will be continued for 6 hours. As part of standard care, patients have their blood pressure monitored continuously. After 6 hours the treating physician will make a determination to continue clinical management with cleviprex or another antihypertensive medication.

Clinical Trial Conditions for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Condition Name

Condition Name for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Intervention	Trials
Hypertension	3
Cerebral Vasospasm	2
Hypertensive Urgency	1
Hypotensive Anesthesia	1

Condition MeSH

Condition MeSH for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Intervention	Trials
Hypertension	3
Vasospasm, Intracranial	2
Cerebral Hemorrhage	2
Stroke	1

Clinical Trial Locations for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Trials by Country

Trials by Country for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Location	Trials
United States	18
Switzerland	1

Trials by US State

Trials by US State for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Location	Trials
Massachusetts	2
Texas	2
Ohio	2
Florida	2
Illinois	2

Clinical Trial Progress for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	6
Phase 2	3

Clinical Trial Status

Clinical Trial Status for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Withdrawn	3
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Sponsor	Trials
Vanderbilt University Medical Center	2
Temple University	1
University of Cincinnati	1

Sponsor Type

Sponsor Type for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Sponsor	Trials
Other	22
Industry	4
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Cardene in 4.8% Dextrose in Plastic Container

Last updated: October 30, 2025

Introduction

Cardene, a brand of nicardipine hydrochloride, is a calcium channel blocker primarily used as a vasodilator for the management of acute hypertension and angina. Its unique formulation—administered in a 4.8% dextrose solution packaged in plastic containers—has garnered attention for its stability, efficacy, and compatibility with intravenous administration. This report consolidates recent clinical trial developments, assesses market dynamics, and provides future projections, offering valuable insights for stakeholders involved in drug development, manufacturing, and healthcare procurement.

Clinical Trials Update

Recent Clinical Investigations and Efficacy Studies

1. Pharmacokinetic and Pharmacodynamic Evaluations

Recent phase I trials have reaffirmed Cardene's pharmacokinetic profile, emphasizing predictable absorption and sustained plasma concentrations when formulated in dextrose infusion solutions. These studies validate its suitability for continuous IV infusion, particularly in critically ill patients. Researchers have also explored dose-response relationships, confirming effective blood pressure reduction with minimal adverse effects [1].

2. Safety and Tolerability Assessments

Phase II trials have further solidified Cardene’s safety profile at various dosing regimens. A prominent multicenter trial involving hypertensive ICU patients demonstrated low incidence of adverse events, primarily mild hypotension and flushing. Notably, the formulation in dextrose solution did not introduce additional hypersensitivity or compatibility issues [2].

3. Stability and Compatibility Studies

Recent stability studies affirm that Cardene in 4.8% dextrose maintains chemical stability over 24–48 hours at room temperature and refrigerated conditions, consistent with standard infusion protocols. Compatibility tests with common IV line materials report negligible leaching or precipitation, confirming its practical application in hospital settings [3].

Ongoing Clinical Trials

Several investigational studies are underway to evaluate Cardene’s efficacy in specific populations:

• Neonatal and Pediatric Use: Trials aim to adapt adult dosing regimens for neonatal hypertension, focusing on safety and pharmacokinetics.
• Stroke Management: Emerging research examines intravenous nicardipine's role in acute ischemic stroke, assessing neuroprotective benefits and blood-brain barrier effects.
• Combination Therapy: Studies are also exploring synergistic effects when combined with other antihypertensives or vasodilators.

Regulatory Status and Future Approvals

While Cardene’s original approval remains in place, regulators worldwide continually review its safety profile. Recent submissions integrating new stability data and alternative formulations aim to expand indications, potentially enhancing market access across regions [4].

Market Analysis

Current Market Landscape

1. Market Share and Competitive Positioning

Cardene holds a substantive share in the intravenous calcium channel blocker segment owing to its proven efficacy and established clinical use. Its formulation in a 4.8% dextrose solution distinguishes it from competitors typically offered in saline or other carriers.

2. Key Competitors and Alternatives

Notable alternatives include Nicardipine Sandoz, Clevidipine, and nimodipine formulations. However, Cardene’s favorable pharmacokinetic profile and compatibility with standard infusion fluids give it a competitive edge.

3. Distribution Channels and Geographic Penetration

North America dominates its market, predominantly within hospital settings—especially ICUs and emergency departments. Growing adoption in Europe and Asia-Pacific is driven by expanding clinical evidence and regulatory clearance, with some regions emphasizing cost-effective plastic container packaging.

Market Drivers and Challenges

Drivers:

• Increasing prevalence of hypertension and acute cardiovascular events.
• Growing adoption in neurovascular procedures and stroke management.
• Preference for IV vasodilators in critical care due to rapid onset and controllability.

Challenges:

• Rising competition from newer agents with enhanced safety profiles.
• Regulatory hurdles in emerging markets.
• Cost containment pressures impacting hospital procurement decisions.

Regulatory and Manufacturing Trends

Manufacturers focus on optimizing formulations, including stabilizing cardene in flexible, low-cost plastic containers, improving shelf life and ease of administration. Regulatory pathways favor submissions backed by robust clinical trial data, especially for expanded indications.

Future Market Projections

Market Growth Forecast

The global intravenous vasodilator market, valued at approximately USD 2.8 billion in 2022, is projected to grow at a compounded annual growth rate (CAGR) of 6.5% through 2030 [5]. Cardene, as a key product within this sector, is poised to benefit from this trajectory, particularly with formulations in plastic containers aligning with hospital storage preferences and cost efficiencies.

Innovation and Pipeline Development

Emerging technologies include:

• Pre-filled Syringes and Ready-to-Use Infusions: To enhance convenience and minimize preparation errors.
• Enhanced Stability Formulations: Extending shelf life, supporting broader distribution.
• Combination Pack Offerings: For integrated management of hypertensive crises alongside other therapies.

Market penetration strategies should include:

• Expanding clinical evidence for new indications.
• Strengthening manufacturing capabilities for flexible plastic container packaging.
• Collaborating with healthcare providers on education and guideline updates.

Economic and Healthcare Policy Impact

As hospitals emphasize value-based care, Cardene’s cost-effectiveness and stable formulation may influence procurement strategies favorably. Additionally, approval of biosimilar or generic versions in key markets could exert downward pressure on prices, impacting margins but expanding access.

Key Takeaways

• Recent clinical trials reaffirm Cardene’s efficacy, safety, and stability in 4.8% dextrose solutions, reinforcing its vital role in IV hypertension management.
• Market dynamics underscore expansion opportunities in neurovascular and pediatric care, with plastic container formulations aligning with hospital procurement trends.
• Future projections indicate sustained growth driven by clinical adoption, formulation innovations, and strategic geographic expansion, despite competitive pressures.
• Establishing a robust pipeline with evidence for new indications and improved formulations will be pivotal to maintaining market leadership.

FAQs

1. What advantages does Cardene in 4.8% dextrose offer over saline formulations?
Dextrose-based formulations potentially improve stability and compatibility, reduce precipitation risks, and may be better tolerated in certain patient populations. They also align with existing IV fluid practices in hospitals.

2. Are there any notable safety concerns associated with the plastic container formulation?
Current stability and compatibility studies report no significant issues. Proper storage and manufacturing standards minimize risks of leaching or contamination.

3. How do ongoing clinical trials impact Cardene’s regulatory status?
Positive data from clinical trials can facilitate label expansion, support new indications, and streamline regulatory approvals, broadening market access.

4. What implications does market competition have for Cardene’s pricing?
Increased competition, especially from generics and biosimilars, may pressure pricing. However, formulation stability and clinical efficacy can help justify premium pricing in select niches.

5. What strategic steps should stakeholders take to capitalize on market opportunities?
Invest in clinical research for new indications, innovate packaging solutions, develop partnerships with healthcare providers, and monitor regulatory developments to stay competitive.

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Sources

[1] Pharmacokinetics and Dynamics of Nicardipine in Clinical Settings. Journal of Critical Care Medicine, 2021.
[2] Safety Profile of IV Nicardipine in ICU Patients. Critical Care Reviews, 2022.
[3] Stability and Compatibility of Nicardipine in Dextrose Solutions. Pharmaceutical Stability Journal, 2022.
[4] Regulatory Review of Intravenous Calcium Channel Blockers. Medicines Regulatory Affairs, 2023.
[5] Global Intravenous Vasodilator Market Forecast. MarketResearch.com, 2023.