CLINICAL TRIALS PROFILE FOR CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

All Clinical Trials for cardene in 0.83% sodium chloride 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Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension	Withdrawn	Facet Biotech	Phase 2	2007-09-01	To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric subjects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.
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.

Clinical Trial Conditions for cardene in 0.83% sodium chloride in plastic container

Condition Name

Condition Name for cardene in 0.83% sodium chloride in plastic container
Intervention	Trials
Hypertension	3
Cerebral Vasospasm	2
Endovascular Thrombectomy	1
Hypertensive Urgency	1

Condition MeSH

Condition MeSH for cardene in 0.83% sodium chloride in plastic container
Intervention	Trials
Hypertension	3
Vasospasm, Intracranial	2
Cerebral Hemorrhage	2
Hypotension	1

Clinical Trial Locations for cardene in 0.83% sodium chloride in plastic container

Trials by Country

Trials by Country for cardene in 0.83% sodium chloride in plastic container
Location	Trials
United States	18
Switzerland	1

Trials by US State

Trials by US State for cardene in 0.83% sodium chloride in plastic container
Location	Trials
Massachusetts	2
Texas	2
Ohio	2
Florida	2
Illinois	2

Clinical Trial Progress for cardene in 0.83% sodium chloride in plastic container

Clinical Trial Phase

Clinical Trial Phase for cardene in 0.83% sodium chloride in plastic container
Clinical Trial Phase	Trials
Phase 4	6
Phase 2	3

Clinical Trial Status

Clinical Trial Status for cardene in 0.83% sodium chloride in plastic container
Clinical Trial Phase	Trials
Withdrawn	3
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for cardene in 0.83% sodium chloride in plastic container

Sponsor Name

Sponsor Name for cardene in 0.83% sodium chloride in plastic container
Sponsor	Trials
Vanderbilt University Medical Center	2
Mayo Clinic	1
National Institute of Neurological Disorders and Stroke (NINDS)	1

Sponsor Type

Sponsor Type for cardene in 0.83% sodium chloride in plastic container
Sponsor	Trials
Other	22
Industry	4
NIH	1