Status:

UNKNOWN

IV Double and Triple Concentrated Nicardipine for Stroke and ICH

Lead Sponsor:

OSF Healthcare System

Collaborating Sponsors:

PDL BioPharma, Inc.

Conditions:

Hypertension

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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) f...

Detailed Description

Hypertension can often cause neurological worsening in patients with either ICH or SAH. Hypertension has been related to increased incidence of intracranial hemorrhage in patients who are treated with...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

January 1 2004

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00325793

Start Date

January 1 2004

Last Update

May 15 2006

Active Locations (1)

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1

OSF Stroke Center

Peoria, Illinois, United States, 61637