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A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00952081
First Posted: August 4, 2009
Last Update Posted: February 9, 2015
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.
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
New York University School of Medicine
Results First Submitted: June 22, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hypertension
Brain Tumor
Epilepsy
Intervention: Drug: Clevidipine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients scheduled for intracranial surgery were prospectively enrolled after giving consent. Clevidipine (0.5 mg/mL in 20% lipid solution, which was to be initiated at 10 mg/h and titrated to effect) was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Clevidipine,Brain Tumor,Hypertension Clevidipine(0.5 mg/mL in 20% lipid solution), initiated at 10 mg/h and titrated to effect, was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.

Participant Flow:   Overall Study
    Clevidipine,Brain Tumor,Hypertension
STARTED   22 
COMPLETED   22 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Clevidipine,Brain Tumor,Hypertension 21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia

Baseline Measures
   Clevidipine,Brain Tumor,Hypertension 
Overall Participants Analyzed 
[Units: Participants]
 		 22 
Age 
[Units: Participants]
 		 
<=18 years   0 
Between 18 and 65 years   21 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation) 		 54  (14.25) 
Gender 
[Units: Participants]
 		 
Female   12 
Male   10 
Region of Enrollment 
[Units: Participants]
 		 
United States   22 


  Outcome Measures

1.  Primary:   The Primary Endpoint of This Trial is the Proportion of Patients Who Did Not Require Rescue Antihypertensive Medication to Maintain SBP Below 130 mmHg (i.e. Clevidipine is a Sole Antihypertensive Agent Used for Blood Pressure Control)   [ Time Frame: intraoperatively and 90 min after surgery ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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:  
Name/Title: Alex Bekker, MD, PhD
Organization: UMDNJ
phone: 973-972-5007
e-mail: bekkeray@umdnj.edu



Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00952081     History of Changes
Other Study ID Numbers: 08-745
First Submitted: July 29, 2009
First Posted: August 4, 2009
Results First Submitted: June 22, 2012
Results First Posted: October 30, 2013
Last Update Posted: February 9, 2015



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