Status:
COMPLETED
Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
EKR Therapeutics, Inc
Conditions:
Hypertensive Urgency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed Description
More than 3 million patients yearly receive an intravenous antihypertensive agent in the US. Despite this large number of critically ill patients treated annually, little research exists in the area o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00765648
Start Date
October 1 2008
End Date
January 1 2010
Last Update
January 6 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic
Cleveland, Ohio, United States, 44122
2
University of Texas Health Science Center
Houston, Texas, United States