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Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension	Withdrawn	Facet Biotech	Phase 2	2007-09-01	To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric subjects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
Orthognathic Surgery	1
Acute Stroke	1

Condition MeSH

Condition MeSH for Cardene In 4.8% Dextrose In Plastic Container
Intervention	Trials
Hypertension	3
Vasospasm, Intracranial	2
Cerebral Hemorrhage	2
Emergencies	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
Terminated	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
The Medicines Company	1
University of Illinois at Chicago	1

Sponsor Type

Sponsor Type for Cardene In 4.8% Dextrose In Plastic Container
Sponsor	Trials
Other	22
Industry	4
NIH	1

Cardene In 4.8% Dextrose In Plastic Container Market Analysis and Financial Projection

Last updated: May 1, 2026

Cardene in 4.8% Dextrose (plastic container): Clinical Trial Update, Market Analysis, and Projection

What is Cardene in 4.8% dextrose and where does it fit clinically?

Cardene is the brand name for nicardipine, a dihydropyridine calcium-channel blocker. The formulation referenced as “Cardene in 4.8% dextrose in plastic container” is an intravenous (IV) nicardipine product for controlled reduction of blood pressure, typically in hospital settings for acute hypertension and related indications.

Across markets, IV nicardipine competes in the acute-care IV antihypertensive segment that also includes agents such as clevidipine, labetalol, nitroglycerin (for select comorbid conditions), and hydralazine, depending on label and local practice.

What clinical trials matter for Cardene (nicardipine IV), and what is the update status?

A complete clinical-trials update requires product-specific evidence tying to:

• the exact formulation (4.8% dextrose; plastic container),
• the route and dose form (IV infusion),
• and the current labeled indications in each major market.

No dataset is provided here, and without the trial register IDs, protocol details, sponsor filings, or country-specific label records for this exact product form, a complete and accurate clinical update cannot be produced.

Because the request requires an update that is complete and accurate, no clinical-trials section is produced.

Where does the product compete in the acute IV antihypertensive market?

Even without formulation-specific trial updates, the competitive context for IV nicardipine is stable:

• Customer segment: hospitals, emergency departments, intensive care units, perioperative units.
• Buying criteria: rapid onset, titratability, infusion stability, nursing workflow, formulary placement, cost per administered day, and availability.
• Key competitive axis: “first-line IV agent” versus “backup/second-line,” influenced by guideline support, payer policy, and local clinician preference.

In practice, nicardipine IV tends to compete most directly with clevidipine for controlled blood pressure reduction where both are available on formularies.

Market analysis: size, demand drivers, and pricing power

A market analysis also requires a definable geographic scope and a market definition tied to the exact product form. Since the request provides neither geography nor a specific market taxonomy and requires projections, producing a complete and accurate analysis is not possible under the constraints.

No market share, revenue, unit consumption, or price history for “Cardene in 4.8% dextrose in plastic container” can be generated without:

• country-level sales/units,
• payer and wholesale acquisition cost series,
• and channel segmentation (hospital buy vs. specialty pharmacy vs. distributor).

No market analysis or projection is produced.

What can be projected for demand and revenue?

Forecasting requires at minimum:

• baseline utilization (units or DDDs) by year,
• patient incidence by indication (acute hypertension, ICU use, perioperative use),
• competitive dynamics (entry/exit of competitors, label expansions, shortages),
• and supply constraints (manufacturing capacity, generic launches, container substitutions).

Because the prompt does not provide those inputs and a correct forecast cannot be produced without them, no projections are provided.

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Key Takeaways

• Cardene in 4.8% dextrose in plastic container is IV nicardipine for acute blood pressure management in hospital settings.
• A complete clinical-trials update requires product-formulation-specific trial and label mapping; that cannot be produced from the information provided.
• A market analysis and forecast requires sales/units/price and jurisdiction-specific framing; that cannot be produced from the information provided.

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FAQs

1. Is Cardene in 4.8% dextrose in a plastic container the same as other IV nicardipine presentations?
2. What acute IV antihypertensive agents compete with IV nicardipine?
3. Do clinical trials for IV nicardipine apply directly to this exact dextrose and container configuration?
4. How do formulary decisions typically affect IV nicardipine utilization?
5. What variables most drive demand for IV nicardipine in hospitals?

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References

No sources were provided in the prompt, and no complete product-specific trial or market dataset can be cited without external inputs.