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Safety and Efficacy of Nicardipine for the Control of Blood Pressure After SAH

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.
 
ClinicalTrials.gov Identifier: NCT00490464
Recruitment Status : Completed
First Posted : June 22, 2007
Last Update Posted : June 22, 2007
Sponsor:
Information provided by:
University of Illinois at Chicago

Tracking Information
First Submitted Date June 20, 2007
First Posted Date June 22, 2007
Last Update Posted Date June 22, 2007
Study Start Date June 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Efficacy of Nicardipine for the Control of Blood Pressure After SAH
Official Title Not Provided
Brief Summary The purpose of this research is to explore ways to improve and simplify control of blood pressure in patients with SAH or ICH. This research will be done by comparing tow different medications that are routinely used to help control blood pressure. None of the medications used in this study nor any procedures performed are experimental.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Defined Population
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Subarachnoid Hemorrhage
  • Intracerebral Hemorrhage
Intervention Drug: Nicardipine and Nipride
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 21, 2007)		 163
Original Actual Enrollment Same as current
Actual Study Completion Date February 2007
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • 18-70 years old (inclusive)
  • Admission to NSICU with a diagnosis of SAH or ICH

Exclusion Criteria:

  • Patients who are admitted >48 hours after SAH or ICH
  • Readmission or second SAH
  • Readmission or second ICH
  • Large (immediately life threatening) associated intraparenchymal or intraventricular hemorrhage
  • Women who are pregnant
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00490464
Other Study ID Numbers 2004-0233
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor University of Illinois at Chicago
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Ben Z Roitberg, MD University of Illinois at Chicago, Department of Neurosurgery
PRS Account University of Illinois at Chicago
Verification Date June 2007