CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 226 enrolled
Drug / intervention
nicardipine intravenous +1 moredrug
Likely dose
nicardipine intravenous 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00765648
NCT00765648Phase 4Completed

A Phase IV, Randomized Trial to Determine the Efficacy and Safety of Cardene Intravenous (I.V.) Versus Labetalol for Management of Hypertensive Emergencies in the Emergency Department Setting

The Cleveland Clinic·interventional·Posted Oct 3, 2008·Updated Jan 6, 2015

In Brief

A Phase 4 clinical trial evaluating nicardipine intravenous and Labetalol for Hypertensive Urgency. Completed, enrolled 226 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 3, 2008
Enrollment StartOct 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.7 years ago

Interventions

nicardipine intravenousdrug

nicardipine 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

Labetaloldrug

Labetalol: 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.