CLINICAL TRIALS PROFILE FOR CARDENE SR

All Clinical Trials for Cardene Sr

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↗	The Effect of Clevidipine on Intracranial Pressure and Cerebral Perfusion Pressure (CCP) in Brain Injured Patients	Withdrawn	The Medicines Company	Phase 4	2011-11-01	Patients with acute brain injury are at risk for complications such as increased pressure in the brain (intracranial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.
NCT01526876 ↗	The Effect of Clevidipine on Intracranial Pressure and Cerebral Perfusion Pressure (CCP) in Brain Injured Patients	Withdrawn	Columbia University	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 Sr

Condition Name

Condition Name for Cardene Sr
Intervention	Trials
Hypertension	3
Cerebral Vasospasm	2
Acute Stroke	1
Endovascular Thrombectomy	1

Condition MeSH

Condition MeSH for Cardene Sr
Intervention	Trials
Hypertension	3
Cerebral Hemorrhage	2
Vasospasm, Intracranial	2
Emergencies	1

Clinical Trial Locations for Cardene Sr

Trials by Country

+

−

Trials by Country for Cardene Sr
Location	Trials
United States	18
Switzerland	1

Trials by US State

+

−

Trials by US State for Cardene Sr
Location	Trials
Massachusetts	2
Texas	2
Ohio	2
Florida	2
Illinois	2

Clinical Trial Progress for Cardene Sr

Clinical Trial Phase

Clinical Trial Phase for Cardene Sr
Clinical Trial Phase	Trials
Phase 4	6
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Cardene Sr
Clinical Trial Phase	Trials
Withdrawn	3
Recruiting	2
Completed	1

Clinical Trial Sponsors for Cardene Sr

Sponsor Name

Sponsor Name for Cardene Sr
Sponsor	Trials
Vanderbilt University Medical Center	2
University of Florida	1
Wake Forest University Health Sciences	1

Sponsor Type

Sponsor Type for Cardene Sr
Sponsor	Trials
Other	22
Industry	4
NIH	1

Cardene SR: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

Cardene SR, a sustained-release formulation of nicardipine hydrochloride, is a calcium channel blocker indicated for the treatment of hypertension. This article delves into the clinical trials, market analysis, and future projections for Cardene SR, providing a thorough understanding of its efficacy, safety, and market position.

Clinical Trials and Efficacy

Antihypertensive Efficacy

Clinical trials have demonstrated the efficacy of Cardene SR in reducing both systolic and diastolic blood pressure in patients with mild to moderate hypertension. These trials, which included in-clinic blood pressure measures and 12 or 24 hour ambulatory blood pressure monitoring, showed significant blood pressure reductions throughout the dosing interval[2][3][5].

Pharmacokinetics

Cardene SR exhibits a unique pharmacokinetic profile. Plasma levels are detectable within 20 minutes, and maximum plasma levels are achieved between 1 and 4 hours after administration. The drug shows a significant reduction in Cmax and a lower bioavailability compared to the immediate-release formulation, except at the highest dose. This results in reduced fluctuation in plasma levels, providing a more stable therapeutic effect[2][3].

Special Populations

• Geriatric Patients: Studies have shown no significant differences in pharmacokinetic parameters between elderly and younger hypertensive patients. However, dose selection for elderly patients should be cautious due to potential decreased hepatic, renal, or cardiac function[2][3].
• Renal Impairment: Patients with moderate renal impairment (creatinine clearance 10-55 mL/min) had higher Cmax and AUC values compared to those with mild impairment. Dose adjustments are necessary for these patients[2][3].
• Liver Disease: Nicardipine plasma levels were higher in patients with severe liver disease, but Cardene SR has not been studied in this population[1].

Safety and Adverse Events

Common Adverse Events

The most common adverse events associated with Cardene SR include headache, pedal edema, vasodilatation, palpitation, nausea, and dizziness. These events were generally not serious, and about 9% of patients withdrew from studies due to adverse events[2][3][5].

Rare Adverse Events

Rare but notable adverse events include hypotension, atypical chest pain, peripheral vascular disorder, ventricular extrasystoles, and various neurological symptoms such as hot flashes, vertigo, and depression[1][3][5].

Market Analysis

Market Position

Cardene SR is part of the calcium channel blocker market, which is a significant segment within the broader antihypertensive drug market. Its sustained-release formulation offers a competitive advantage by providing a more stable and consistent therapeutic effect, which can improve patient compliance.

Competitors

The antihypertensive market is highly competitive, with other calcium channel blockers like amlodipine and nifedipine, as well as other classes of antihypertensive drugs such as ACE inhibitors and beta-blockers. However, Cardene SR's unique pharmacokinetic profile and the convenience of its sustained-release formulation help it maintain a niche in the market.

Market Trends

The global antihypertensive drug market is growing due to increasing prevalence of hypertension, an aging population, and rising awareness about cardiovascular health. The trend towards more patient-friendly and compliance-enhancing formulations like Cardene SR is expected to continue, driving demand for such products.

Projections and Future Outlook

Market Growth

Given the increasing prevalence of hypertension and the need for effective and convenient antihypertensive treatments, the market for Cardene SR is expected to grow. The global antihypertensive market is projected to continue its upward trend, driven by demographic changes and advancements in healthcare.

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market success of any drug. Cardene SR, being an established product, is likely to benefit from its existing regulatory approvals. However, any changes in regulatory standards or the introduction of new guidelines could impact its market position.

Innovation and Development

The pharmaceutical industry is constantly evolving, with new drugs and formulations being developed. To maintain its market share, the manufacturer of Cardene SR may need to invest in further research and development, potentially exploring new indications or improving the existing formulation.

Key Takeaways

• Efficacy: Cardene SR is effective in reducing blood pressure in patients with mild to moderate hypertension.
• Pharmacokinetics: It offers a stable therapeutic effect with reduced plasma level fluctuations.
• Safety: Common adverse events are generally mild, but rare events can be serious.
• Market Position: Cardene SR holds a niche in the antihypertensive market due to its sustained-release formulation.
• Projections: The market for Cardene SR is expected to grow driven by increasing hypertension prevalence and demand for patient-friendly formulations.

FAQs

What is Cardene SR used for?

Cardene SR is indicated for the treatment of hypertension and can be used alone or in combination with other antihypertensive drugs[2][3][5].

What are the common adverse events associated with Cardene SR?

Common adverse events include headache, pedal edema, vasodilatation, palpitation, nausea, and dizziness[2][3][5].

How does Cardene SR differ from other calcium channel blockers?

Cardene SR has a sustained-release formulation, which provides a more stable and consistent therapeutic effect compared to immediate-release formulations[2][3].

Can Cardene SR be used in patients with renal impairment?

Yes, but doses need to be adjusted for patients with moderate renal impairment due to higher Cmax and AUC values[2][3].

What is the impact of food on Cardene SR absorption?

Taking Cardene SR with a high-fat meal reduces the fluctuation in plasma levels by lowering Cmax and AUC and increasing trough levels[1].

Are there any contraindications for Cardene SR?

Cardene SR is contraindicated in patients with hypersensitivity to the drug and in those with advanced aortic stenosis[1][3][5].

Sources

1. CARDENE® SR - (nicardipine hydrochloride) - FDA Label.
2. Cardene: Package Insert / Prescribing Information - Drugs.com.
3. CARDENE SR- nicardipine hydrochloride capsule - DailyMed.
4. Seventh Report of the Joint National Committee on Prevention - American Heart Association.
5. Cardene SR (Nicardipine Hydrochloride Sustained Release) - RxList.