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

NeuroTherapia, Inc.

Status and phase: Completed; Phase 4

Conditions: Hypertensive Urgency

Treatments: Drug: nicardipine intravenous; Drug: Labetalol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00765648

2008-001

Details and patient eligibility

About

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.

Full 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 of acute severe hypertension, specifically hypertensive emergency, a serious condition that contributes to morbidity and mortality.

Two agents that are commonly used to treat acute hypertensive crisis include labetalol and nicardipine. Cardene may provide benefits in titration and has shown to have lower dosage adjustments compared to labetalol. Nicardipine has also shown a decreased need for additional antihypertensives when compared to labetalol in patients with stroke in a neurological ICU.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

1

Active Comparator group

Description:

nicardipine intravenous

Treatment:

Drug: nicardipine intravenous

2

Active Comparator group

Description:

Labetalol

Treatment:

Drug: Labetalol