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

This study has been completed.
Sponsor:
Collaborator:
EKR Therapeutics, Inc
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00765648
First received: October 1, 2008
Last updated: January 19, 2010
Last verified: January 2010
  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: Cardene I.V.
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 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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Variability in BP: Efficacy of BP control by comparing the AUC of BP-time curve between nicardipine and labetalol [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Determine heart rate profile during treatment and during ED therapy [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Number of dose titrations for Cardene I.V. versus labetalol within 30 minutes [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • ED time to disposition decision [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Treatment failure as defined by admission to the hospital or observation unit for BP management [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • The percent of subjects requiring the use of IV rescue medications [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Transition time to oral medication [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Determine the pharmacoeconomic impact of the use of Cardene I.V. compared to labetalol [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

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
Cardene I.V
Drug: Cardene I.V.
Cardene I.V.: 5 mg/h titrated every 5 minutes by 2.5 mg/h until TSBPR is reached or maximum dose of 15 mg/hour is achieved.Following achievement of TSBPR the infusion rate should be decreased to 3 mg/hr
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 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 BP≥180 mm Hg on 2 consecutive readings(10 min apart)presenting in the ED

Exclusion Criteria:

  • Use of any investigational drug within 1 month prior to ED
  • Pregnant or breast-feeding females
  • Contraindications or allergy to beta-blockers and calcium channel blockers (see FDA approved labeling for Cardene I.V. and labetalol)
  • Subjects with decompensated CHF or with a known LVEF <35%
  • History of stroke within 30 days
  • Known liver failure
  • Suspected myocardial infarction
  • Suspected aortic dissection
  • Suspected cocaine overdose
  • Concurrently receiving other 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: W. Frank Peacock IV, MD, Vice Chair Research, Department of Emergency Medicine, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00765648     History of Changes
Other Study ID Numbers: 2008-001
Study First Received: October 1, 2008
Last Updated: January 19, 2010
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 alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic 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 October 23, 2014