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

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ClinicalTrials.gov Identifier: NCT00765648
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : December 11, 2014
Last Update Posted : January 6, 2015
Sponsor:
Collaborator:
EKR Therapeutics, Inc
Information provided by (Responsible Party):
The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 3, 2008
Results First Submitted Date  ICMJE July 18, 2011
Results First Posted Date  ICMJE December 11, 2014
Last Update Posted Date January 6, 2015
Study Start Date  ICMJE October 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
Percentage of subjects achieving a pre-defined target systolic BP range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator. [ Time Frame: 30 minutes after initiation of therapy ]
Change History Complete list of historical versions of study NCT00765648 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
  • 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
  • Emergency Department(ED)Time to Disposition Decision [ Time Frame: 6 hours ]
    Median number of hours from hospital admission until Emergency Department(ED)disposition
  • Treatment Failure [ Time Frame: 6 hours ]
    Treatment failure is defined as admission to the hospital or observation unit for BP management
  • Subjects Requiring the Use of Intravenous Rescue Medications [ Time Frame: 6 hours ]
    The percent of subjects requiring the use of intravenous rescue medications
  • Transition Time to Oral Medication [ Time Frame: 6 hours ]
    The median transition time (in hours) to oral medication
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
  • Variability in BP: Efficacy of BP control by comparing the AUC of BP-time curve between nicardipine and labetalol [ Time Frame: 6 hours ]
  • Determine heart rate profile during treatment and during ED therapy [ Time Frame: 6 hours ]
  • Number of dose titrations for Cardene I.V. versus labetalol within 30 minutes [ Time Frame: 6 hours ]
  • ED time to disposition decision [ Time Frame: 6 hours ]
  • Treatment failure as defined by admission to the hospital or observation unit for BP management [ Time Frame: 6 hours ]
  • The percent of subjects requiring the use of IV rescue medications [ Time Frame: 6 hours ]
  • Transition Time to Oral Medication [ Time Frame: 6 hours ]
  • Determine the pharmacoeconomic impact of the use of Cardene I.V. compared to labetalol [ Time Frame: 6 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertensive Urgency
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: 1
    nicardipine intravenous
    Intervention: Drug: nicardipine intravenous
  • Active Comparator: 2
    Labetalol
    Intervention: Drug: Labetalol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2008)
226
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00765648
Other Study ID Numbers  ICMJE 2008-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE EKR Therapeutics, Inc
Investigators  ICMJE
Principal Investigator: W. Frank Peacock, MD The Cleveland Clinic
Principal Investigator: Joseph Varon, MD The University of Texas Health Science Center, Houston
PRS Account The Cleveland Clinic
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP