We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00765648
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : December 11, 2014
Last Update Posted : January 6, 2015
EKR Therapeutics, Inc
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Hypertensive Urgency Drug: nicardipine intravenous Drug: Labetalol Phase 4

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
nicardipine intravenous
Drug: nicardipine intravenous
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
Other Name: Nicardipine hydrochloride

Active Comparator: 2
Drug: Labetalol
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.

Primary Outcome Measures :
  1. Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. [ Time Frame: 30 minutes after initiation of therapy ]
    Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator.

Secondary Outcome Measures :
  1. Average Number of Dose Titrations Within 30 Minutes [ Time Frame: 30 minutes ]
    Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group

  2. Emergency Department(ED)Time to Disposition Decision [ Time Frame: 6 hours ]
    Median number of hours from hospital admission until Emergency Department(ED)disposition

  3. Treatment Failure [ Time Frame: 6 hours ]
    Treatment failure is defined as admission to the hospital or observation unit for BP management

  4. Subjects Requiring the Use of Intravenous Rescue Medications [ Time Frame: 6 hours ]
    The percent of subjects requiring the use of intravenous rescue medications

  5. Transition Time to Oral Medication [ Time Frame: 6 hours ]
    The median transition time (in hours) to oral medication

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765648

Layout table for location information
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44122
United States, Texas
University of Texas Health Science Center
Houston, Texas, United States
Sponsors and Collaborators
The Cleveland Clinic
EKR Therapeutics, Inc
Layout table for investigator information
Principal Investigator: W. Frank Peacock, MD The Cleveland Clinic
Principal Investigator: Joseph Varon, MD The University of Texas Health Science Center, Houston
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00765648    
Other Study ID Numbers: 2008-001
First Posted: October 3, 2008    Key Record Dates
Results First Posted: December 11, 2014
Last Update Posted: January 6, 2015
Last Verified: July 2011
Keywords provided by The Cleveland Clinic:
emergency department
hypertensive emergency
hypertensive urgency
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease Attributes
Pathologic Processes
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents