IV Double and Triple Concentrated Nicardipine for Stroke and ICH

NCT00325793 | Unknown Phase 4

• 1 other identifier: 0012003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

nicardipine; hypertension; intracerebral hemorrhage; ischemic stroke

Outcome Measures

Primary Outcomes (1)

• • Demonstrate the feasibility and safety of double and triple concentrated peripheral intravenous Nicardipine for patients in the Neuroscience Critical Care Unit.

Secondary Outcomes (3)

• Time and dosage adjustment needed to reach the target BP range

• Safety

• To evaluate the tolerance of the double or triple concentrated Nicardipine

Interventions

Nicardipine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, 18 years of age or older.
• Acute ischemic cerebral stroke (IS) with uncontrollable hypertension that may need to be controlled for the purpose of considering thrombolytic therapy or anticoagulation therapy.
• Intracerebral hemorrhagic (ICH) stroke patients, including subarachnoid hemorrhage (SAH) (surgically treated or not), any territory with an appropriate study (head CT scan or MRI scan) providing results consistent with this diagnosis, who may require the control of hypertension or control of blood pressure.

You may not qualify if:

• Allergy to Nicardipine or known hypersensitivity to Nicardipine.
• Chronic renal failure or Creatinine blood sample levels\> 2.0.
• Impaired hepatic function defined as a two times value of liver enzymes.
• Severe left ventricular dysfunction defined as ventricular ejection fraction \< 30%.
• Patients or authorized representative who refused be enrolled into this study.
• Advanced aortic stenosis.
• Pregnant or nursing women will not be enrolled in this study.
• No patient will be allowed to be enrolled in this study more than once.
• Patients may not be enrolled into other clinical studies during their involvement with this study.

Sponsors & Collaborators

• OSF Healthcare System: lead
• PDL BioPharma, Inc.: collaborator

Study Sites (1)

OSF Stroke Center

Peoria, Illinois, 61637, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Cerebral Hemorrhage; Ischemic Stroke

Interventions

Nicardipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Wang, DO

  OSF Stroke Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Wang, DO

CONTACT

309-624-9500; dwang@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 12, 2006
• First Posted: May 15, 2006
• Study Start: January 1, 2004
• Last Updated: May 15, 2006

Record last verified: 2006-05

Locations

US (1)