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

This study has been completed.
Sponsor:
Collaborator:
EKR Therapeutics, Inc
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00765648
First received: October 1, 2008
Last updated: December 11, 2014
Last verified: July 2011
  Purpose

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 Intervention Phase
Hypertensive Urgency
Drug: nicardipine intravenous
Drug: Labetalol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. [ Time Frame: 30 minutes after initiation of therapy ] [ Designated as safety issue: No ]
    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:
  • Average Number of Dose Titrations Within 30 Minutes [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Median number of hours from hospital admission until Emergency Department(ED)disposition

  • Treatment Failure [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The percent of subjects requiring the use of intravenous rescue medications

  • Transition Time to Oral Medication [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    The median transition time (in hours) to oral medication


Enrollment: 226
Study Start Date: October 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Labetalol
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765648

Locations
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
Investigators
Principal Investigator: W. Frank Peacock, MD The Cleveland Clinic
Principal Investigator: Joseph Varon, MD The University of Texas Health Science Center, Houston
  More Information

No publications provided by The Cleveland Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00765648     History of Changes
Other Study ID Numbers: 2008-001
Study First Received: October 1, 2008
Results First Received: July 18, 2011
Last Updated: December 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
hypertension
emergency department
Nicardipine
Labetalol
hypertensive emergency
hypertensive urgency

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Labetalol
Nicardipine
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Autonomic Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on April 19, 2015