CLINICAL TRIALS PROFILE FOR CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

All Clinical Trials for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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↗	The Effect of Clevidipine on Intracranial Pressure and Cerebral Perfusion Pressure (CCP) in Brain Injured Patients	Withdrawn	The Medicines Company	Phase 4	2011-11-01	Patients with acute brain injury are at risk for complications such as increased pressure in the brain (intracranial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.
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.
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.
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.

Clinical Trial Conditions for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Condition Name

Condition Name for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
Intervention	Trials
Hypertension	3
Cerebral Vasospasm	2
Hypertensive Urgency	1
Hypotensive Anesthesia	1

Condition MeSH

Condition MeSH for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
Intervention	Trials
Hypertension	3
Vasospasm, Intracranial	2
Cerebral Hemorrhage	2
Stroke	1

Clinical Trial Locations for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
Location	Trials
United States	18
Switzerland	1

Trials by US State

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Trials by US State for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
Location	Trials
Massachusetts	2
Texas	2
Ohio	2
Florida	2
Illinois	2

Clinical Trial Progress for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	6
Phase 2	3

Clinical Trial Status

Clinical Trial Status for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Withdrawn	3
Recruiting	2
Completed	1

Clinical Trial Sponsors for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
Sponsor	Trials
Vanderbilt University Medical Center	2
EKR Therapeutics, Inc	1
Thomas Jefferson University	1

Sponsor Type

Sponsor Type for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
Sponsor	Trials
Other	22
Industry	4
NIH	1

Clinical Trials, Market Analysis, and Projections for Cardene In 5.0% Dextrose In Plastic Container

Introduction

Cardene, also known as nicardipine hydrochloride, is a potent calcium channel blocker with significant vasodilator action, commonly used for its antihypertensive properties. This article will delve into the current state of clinical trials, market analysis, and future projections for Cardene In 5.0% Dextrose In Plastic Container.

Clinical Trials Overview

While specific ongoing clinical trials for Cardene In 5.0% Dextrose In Plastic Container are not widely reported in recent sources, it is essential to understand the stability and efficacy of nicardipine hydrochloride in various intravenous solutions.

Stability Studies

Studies on the stability of nicardipine hydrochloride in intravenous solutions indicate that the drug is not stable in certain conditions. For instance, nicardipine hydrochloride is unstable in 5% sodium bicarbonate injection and in PVC bags containing lactated Ringer's injection or 5% dextrose and lactated Ringer's injection. However, it remains stable in glass containers for up to seven days in solutions such as 5% dextrose and 0.9% sodium chloride injection[3].

Implications for Clinical Use

The stability data are crucial for clinical trials and routine clinical use, as they dictate the appropriate storage and administration methods to ensure the drug's efficacy and safety. For example, avoiding PVC containers and using glass containers can help maintain the drug's concentration over time.

Market Analysis

Current Market Dynamics

The market for nicardipine hydrochloride is poised for significant growth driven by increasing demand and favorable market dynamics. The expanding healthcare sector, particularly in the area of cardiovascular treatments, contributes to this growth[5].

Generic Market

Nicardipine hydrochloride has been available in generic forms since the early 2000s, with multiple ANDAs (Abbreviated New Drug Applications) submitted and approved. This generic competition can influence pricing and market share but also ensures a steady supply of the drug[5].

Market Segmentation

The market can be segmented based on the type of formulation (e.g., Cardene In 5.0% Dextrose In Plastic Container) and the geographical region. The demand for intravenous formulations like Cardene is particularly high in hospital settings and intensive care units.

Market Projections

Growth Drivers

Several factors are expected to drive the growth of the nicardipine hydrochloride market:

• Increasing Prevalence of Hypertension: The rising incidence of hypertension and other cardiovascular diseases is expected to increase the demand for antihypertensive medications like nicardipine hydrochloride.
• Advancements in Healthcare: Improvements in healthcare infrastructure and access to medical services, especially in developing countries, will further boost the market.
• Generic Competition: The availability of generic versions of nicardipine hydrochloride will continue to drive market growth by offering cost-effective alternatives to branded products[5].

Challenges

Despite the growth potential, there are challenges to consider:

• Stability Issues: The instability of nicardipine hydrochloride in certain solutions can affect its shelf life and clinical efficacy, necessitating careful handling and storage.
• Regulatory Compliance: Manufacturers must adhere to stringent regulatory requirements, which can impact production and distribution.

Competitive Landscape

Key Players

The market for nicardipine hydrochloride includes several key players, both branded and generic. Companies like Bausch Health (formerly Valeant Pharmaceuticals) have been significant players in the market. Generic manufacturers also play a crucial role in providing affordable alternatives[5].

Market Share

The market share is distributed among branded and generic manufacturers. Generic versions, due to their cost-effectiveness, often capture a significant portion of the market share.

Future Outlook

Technological Advancements

Future advancements in formulation technology could improve the stability and efficacy of nicardipine hydrochloride. For instance, new container materials or formulations that enhance stability in various solutions could be developed.

Regulatory Updates

Regulatory updates and changes in FDA guidelines can impact the market. For example, any new requirements for stability testing or clinical trials could influence the development and approval process for new formulations.

Global Expansion

The global expansion of healthcare services and the increasing demand for cardiovascular treatments in emerging markets are expected to drive the growth of the nicardipine hydrochloride market.

Key Takeaways

• Stability Concerns: Nicardipine hydrochloride has stability issues in certain intravenous solutions, which must be addressed to ensure efficacy.
• Market Growth: The market is expected to grow due to increasing demand, favorable market dynamics, and the expanding healthcare sector.
• Generic Competition: Generic versions of nicardipine hydrochloride play a significant role in the market, offering cost-effective alternatives.
• Future Advancements: Technological advancements and regulatory updates will shape the future of the nicardipine hydrochloride market.

FAQs

What is the primary use of Cardene In 5.0% Dextrose In Plastic Container?

Cardene In 5.0% Dextrose In Plastic Container is primarily used as an antihypertensive medication due to its calcium channel blocking and vasodilator properties.

Why is stability testing important for nicardipine hydrochloride?

Stability testing is crucial to ensure that the drug remains effective and safe for use. Nicardipine hydrochloride has been shown to be unstable in certain solutions, which can affect its clinical efficacy.

What are the growth drivers for the nicardipine hydrochloride market?

The growth drivers include the increasing prevalence of hypertension, advancements in healthcare, and the availability of generic versions of the drug.

Who are the key players in the nicardipine hydrochloride market?

Key players include both branded and generic manufacturers, with companies like Bausch Health and various generic manufacturers playing significant roles.

What are the potential challenges for the nicardipine hydrochloride market?

Challenges include stability issues, regulatory compliance, and the need for careful handling and storage to maintain the drug's efficacy.

Sources

1. Cabaletta Bio Presents Positive Clinical Safety and Efficacy Data on CABA-201 - Not directly relevant but provides context on clinical trial design and FDA interactions.
2. Cardene In 4.8% Dextrose In Plastic Container - Provides detailed chemical and pharmaceutical information about Cardene.
3. Stability of nicardipine hydrochloride in intravenous solutions - Critical for understanding the stability of the drug in various solutions.
4. Cadrenal Therapeutics Provides 2024 Year-End Company Update - Not directly relevant but offers insights into clinical trial processes and FDA interactions.
5. NICARDIPINE HYDROCHLORIDE - Generic Drug Details - Provides market and regulatory information about nicardipine hydrochloride.