Phase 4
Completed N=226
Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department
Hypertensive Urgency
Source: ClinicalTrials.gov NCT00765648 ↗
Enrolled (actual)
226
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. — 91.7; 82.5 percentage of participants — p=0.04
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. |
91.7; 82.5 | 0.04 sig |
| SECONDARY Average Number of Dose Titrations Within 30 Minutes |
2.2; 1.3 | <0.001 sig |
| SECONDARY Emergency Department(ED)Time to Disposition Decision |
4.6; 4.6 | 0.76 |
| SECONDARY Treatment Failure |
43.1; 37.4 | 0.38 |
| SECONDARY Subjects Requiring the Use of Intravenous Rescue Medications |
15.5; 22.4 | 0.18 |
| SECONDARY Transition Time to Oral Medication |
4.9; 6.4 | 0.11 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00765648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.