Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- The Cleveland Clinic
- Study ID
- NCT00765648
- Phase
- PHASE4
- Status
- Completed
Conditions
- Hypertensive Urgency
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- nicardipine intravenous — DRUGnicardipine intravenous 5 mg/hour titrated every 5 minutes by 2.5 mg/hour until target systolic blood pressure range (TSBPR) is reached or maximum dose of 15 mg/hour is achieved.Following achievement of target systolic blood pressure range the infusion rate should be decreased to 3 mg/hour
- Labetalol — DRUGLabetalol: bolus therapy to start at 20 mg intravenous injection over 2 minutes, may repeat 20mg, 40mg or 80mg injections every 10 minutes until target systolic blood pressure range(TSBPR)is reached or a maximum of 300 mg is injected.
Study Details
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.
Key Dates
- Start date
- Oct 31, 2008
- Status verified
- Jul 2011
- Primary completion
- Jan 31, 2010
- Completion
- Jan 31, 2010
Study Design
- Enrollment
- 226 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: 1nicardipine intravenous
- Active Comparator: 2Labetalol
Primary Outcome Measure
Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. [ Time Frame: 30 minutes after initiation of therapy ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44122 | - |
| University of Texas Health Science Center | Houston | Texas | - | - |
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