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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertensive Urgency
Interventions Drug: nicardipine intravenous
Drug: Labetalol
Enrollment 226
Recruitment Details Eligible patients had 2 systolic blood pressures(BP) measures > 180 mmHg at least 10 minutes apart, and no contraindications.Emergency room setting.
Pre-assignment Details  
Arm/Group Title Nicardipine Dosing Was 5 mg/Hour Bolus Labetalol Began at 20 mg Over 2 Minutes
Hide Arm/Group Description nicardipine intravenous Labetalol
Period Title: Overall Study
Started 110 116
Completed 109 114
Not Completed 1 2
Arm/Group Title Nicardipine Dosing Was 5 mg/Hour Bolus Labetalol Began at 20 mg Over 2 Minutes Total
Hide Arm/Group Description nicardipine intravenous Labetalol Total of all reporting groups
Overall Number of Baseline Participants 110 116 226
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 116 participants 226 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
81
  73.6%
98
  84.5%
179
  79.2%
>=65 years
29
  26.4%
18
  15.5%
47
  20.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 116 participants 226 participants
Female
60
  54.5%
59
  50.9%
119
  52.7%
Male
50
  45.5%
57
  49.1%
107
  47.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 110 participants 116 participants 226 participants
110 116 226
1.Primary Outcome
Title Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.
Hide Description 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.
Time Frame 30 minutes after initiation of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat cohort.
Arm/Group Title Nicardipine Labetalol
Hide Arm/Group Description:
Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Overall Number of Participants Analyzed 109 114
Measure Type: Number
Unit of Measure: percentage of participants
91.7 82.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicardipine, Labetalol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -9.3
Confidence Interval (2-Sided) 95%
-18.0 to -0.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Average Number of Dose Titrations Within 30 Minutes
Hide Description Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicardipine Labetalol
Hide Arm/Group Description:
Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Overall Number of Participants Analyzed 109 114
Mean (Standard Deviation)
Unit of Measure: number of titrations
2.2  (1) 1.3  (0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicardipine, Labetalol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Emergency Department(ED)Time to Disposition Decision
Hide Description Median number of hours from hospital admission until Emergency Department(ED)disposition
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
these are the correct participant numbers for this secondary analysis
Arm/Group Title Nicardipine Labetalol
Hide Arm/Group Description:
Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Overall Number of Participants Analyzed 109 115
Median (Inter-Quartile Range)
Unit of Measure: hours
4.6
(3.5 to 6.6)
4.6
(3.1 to 7.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicardipine, Labetalol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Treatment Failure
Hide Description Treatment failure is defined as admission to the hospital or observation unit for BP management
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
these are the correct participant numbers for this secondary analysis
Arm/Group Title Nicardipine Labetalol
Hide Arm/Group Description:
Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Overall Number of Participants Analyzed 109 115
Measure Type: Number
Unit of Measure: percentage of participants
43.1 37.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicardipine, Labetalol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Subjects Requiring the Use of Intravenous Rescue Medications
Hide Description The percent of subjects requiring the use of intravenous rescue medications
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicardipine Labetalol
Hide Arm/Group Description:
Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Overall Number of Participants Analyzed 110 116
Measure Type: Number
Unit of Measure: percentage of participants
15.5 22.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicardipine, Labetalol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Transition Time to Oral Medication
Hide Description The median transition time (in hours) to oral medication
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
these are the correct participant numbers for this secondary analysis
Arm/Group Title Nicardipine Labetalol
Hide Arm/Group Description:
Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Overall Number of Participants Analyzed 96 85
Median (Inter-Quartile Range)
Unit of Measure: hours
4.9
(1.4 to 10.9)
6.4
(2.2 to 16.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicardipine, Labetalol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Emergency Room visit
Adverse Event Reporting Description Elevated cardiac markers
 
Arm/Group Title Nicardipine Labetalol
Hide Arm/Group Description Nicardipine dosing was 5 mg/hour Bolus Labetalol began at 20 mg over 2 minutes
All-Cause Mortality
Nicardipine Labetalol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nicardipine Labetalol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/110 (0.00%)      0/116 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nicardipine Labetalol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/110 (0.91%)      0/116 (0.00%)    
Cardiac disorders     
Elevated cardiac biomarkers  1  1/110 (0.91%)  1 0/116 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Frank Peacock MD
Organization: Cleveland Clinic
Phone: (216) 445-4557
EMail: peacocw@ccf.org
Layout table for additonal information
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00765648     History of Changes
Other Study ID Numbers: 2008-001
First Submitted: October 1, 2008
First Posted: October 3, 2008
Results First Submitted: July 18, 2011
Results First Posted: December 11, 2014
Last Update Posted: January 6, 2015