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Simvastatin For Intracerebral Hemorrhage Study

This study has been terminated.
(Poor recruitment, trial terminated)
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00718328
First received: July 15, 2008
Last updated: May 7, 2017
Last verified: May 2017
Results First Received: May 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Intracerebral Hemorrhage
Interventions: Drug: Simvastatin 80 mg
Drug: Placebo

  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
Recruitment period October 2008- June 2009, Inpatient (ICU)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No issues prior to assignment

Reporting Groups
  Description
Simvastatin Group Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
Placebo Group Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.

Participant Flow:   Overall Study
    Simvastatin Group   Placebo Group
STARTED   1   0 
COMPLETED   0 [1]   0 [2] 
NOT COMPLETED   1   0 
Lost to Follow-up                1                0 
[1] Prematurely terminated due to poor enrollment
[2] Terminated due to poor enrollment



  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.
No text entered.

Reporting Groups
  Description
Simvastatin Group Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
Placebo Group Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
Total Total of all reporting groups

Baseline Measures
   Simvastatin Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   0   1 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%   0      0   0.0% 
Between 18 and 65 years      1 100.0%   0      1 100.0% 
>=65 years      0   0.0%   0      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 62 
 (62 to 62) 
    62 
 (62 to 62) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%         0   0.0% 
Male      1 100.0%         1 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   1      1 


  Outcome Measures

1.  Primary:   Perihematomal Edema   [ Time Frame: Days 7 and 14 ]

2.  Secondary:   Mortality   [ Time Frame: 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Functional Outcomes Using Modified Rankin Score, Barthel Index   [ Time Frame: 90 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Neeraj Naval
Organization: Johns Hopkins University SOM (former employer during the study)
phone: 9042026290
e-mail: neerajnaval@gmail.com


Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00718328     History of Changes
Other Study ID Numbers: NA_00016284
NIH UL1 RR 025005
Study First Received: July 15, 2008
Results First Received: May 7, 2017
Last Updated: May 7, 2017