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Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension	Withdrawn	Facet Biotech	Phase 2	2007-09-01	To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric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

Condition MeSH

Condition MeSH for Cardene In 4.8% Dextrose In Plastic Container
Intervention	Trials
Hypertension	3
Cerebral Hemorrhage	2
Vasospasm, Intracranial	2
Hypotension	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
Brigham and Women's Hospital	1
Yale University	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: Clinical Trials, Market Analysis, and Projections

Overview of Cardene

Cardene, whose active ingredient is nicardipine hydrochloride, is a calcium channel blocker used primarily to treat hypertension and chronic stable angina. Here, we will delve into the clinical trials, market analysis, and projections for Cardene in 4.8% Dextrose in Plastic Container.

Clinical Trials

Efficacy in Hypertension and Angina

Clinical trials have demonstrated the efficacy of Cardene in managing hypertension and chronic stable angina. In patients with coronary artery disease, Cardene has shown significant improvements in exercise tolerance, reduced nitroglycerin consumption, and decreased frequency of anginal attacks[1][4].

Hemodynamic Effects

Hemodynamic studies have revealed that Cardene increases ejection fraction and cardiac output without significantly altering left ventricular end-diastolic pressure (LVEDP). It also improves coronary blood flow, enhancing perfusion and aerobic metabolism in areas with chronic ischemia[1][4].

Adverse Events

Clinical trials have identified common adverse events associated with Cardene, including headache, hypotension, tachycardia, and nausea/vomiting. These events were generally not serious and occasionally required dosage adjustments. Therapy was discontinued in about 12% of patients, mainly due to these adverse effects[4].

Special Populations

In patients with severe liver disease, plasma concentrations of nicardipine were elevated, and the half-life was prolonged, indicating the need for cautious dosing in such patients[4].

Market Analysis

Market Size and Growth

The calcium channel blocker market, which includes Cardene, has seen strong growth in recent years. The global market size is expected to grow from $14.72 billion in 2023 to $15.75 billion in 2024 at a CAGR of 7.0%. By 2028, the market is projected to reach $20.64 billion[5].

Competitive Landscape

Cardene in 4.8% Dextrose in Plastic Container is marketed by Chiesi and is protected by six US patents and twenty-one international patent family members. The generic version of nicardipine hydrochloride was approved by ANI PHARMS in 1996, indicating a competitive market with both branded and generic options available[3].

Market Trends

Key trends driving the growth of the calcium channel blocker market include the rising global burden of cardiovascular diseases, advancements in medical research, changing lifestyles, and increased awareness. Technological advancements and regulatory approvals are also expected to play significant roles in market expansion[5].

Projections

Market Forecast

Given the strong growth trajectory of the calcium channel blocker market, Cardene is likely to benefit from the increasing demand for cardiovascular treatments. The market's CAGR of 7.0% from 2023 to 2028 suggests a robust future for drugs like Cardene[5].

Patent Expiration and Generic Competition

The protection offered by patents for Cardene in 4.8% Dextrose in Plastic Container will eventually expire, which could lead to increased generic competition. However, the brand's established reputation and ongoing clinical trials may help maintain its market share[3].

Regulatory Landscape

Regulatory approvals and expansions of indications will continue to influence the market. As new clinical trials and studies emerge, Cardene may see its uses broadened, further solidifying its position in the market[5].

Key Takeaways

• Clinical Efficacy: Cardene has demonstrated significant efficacy in treating hypertension and chronic stable angina through improved exercise tolerance and reduced anginal attacks.
• Hemodynamic Effects: The drug enhances cardiac output and coronary blood flow without adverse effects on LVEDP.
• Adverse Events: Common adverse events include headache, hypotension, and tachycardia, which are generally manageable.
• Market Growth: The calcium channel blocker market is expected to grow at a CAGR of 7.0% from 2023 to 2028.
• Competitive Landscape: The market is competitive with both branded and generic options available, driven by technological advancements and regulatory approvals.

FAQs

What is the primary use of Cardene in 4.8% Dextrose in Plastic Container?

Cardene in 4.8% Dextrose in Plastic Container is primarily used to treat hypertension and chronic stable angina.

What are the common adverse events associated with Cardene?

Common adverse events include headache, hypotension, tachycardia, and nausea/vomiting.

How does Cardene affect hemodynamics in patients with coronary artery disease?

Cardene increases ejection fraction and cardiac output without significantly altering left ventricular end-diastolic pressure (LVEDP) and improves coronary blood flow.

What is the projected growth rate of the calcium channel blocker market?

The calcium channel blocker market is expected to grow at a CAGR of 7.0% from 2023 to 2028.

Are there generic versions of Cardene available?

Yes, a generic version of nicardipine hydrochloride was approved by ANI PHARMS in 1996.

Sources

1. CARDENE - accessdata.fda.gov
2. Beta Carotene Market Size, Share & Growth Outlook 2024-2032 - Polaris Market Research
3. CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER Drug - Drug Patent Watch
4. HIGHLIGHTS OF PRESCRIBING INFORMATION - Baxter PI
5. Global Calcium Channel Blocker Market Report 2024 - The Business Research Company