Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: EKR Therapeutics, Inc
• Treatments: Labetalol; Nicardipine

Criteria

Inclusion Criteria:

• 18 years of age or older

• Systolic blood pressure ≥180 mm Hg on 2 consecutive readings(10 minutes apart)presenting in the emergency department (ED)

Exclusion Criteria:

• Use of any investigational drug within 1 month prior to emergency department (ED)

• Pregnant or breast-feeding females

• Contraindications or allergy to beta-blockers and calcium channel blockers (see FDA approved labeling for nicardipine intravenous and labetalol)

• Subjects with decompensated congestive heart failure (CHF) or with a known left ventricular ejection fraction (LVEF) <35%

• History of stroke within 30 days

• Known liver failure

• Suspected myocardial infarction

• Suspected aortic dissection

• Suspected cocaine overdose

• Concurrently receiving other intravenous (I.V.) hypertensive medications