Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00200356
First received: September 12, 2005
Last updated: December 9, 2012
Last verified: December 2012
Results First Received: September 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cerebral Infarction
Interventions: Drug: Edaravone
Drug: Sodium Ozagrel

  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
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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
Edaravone Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Ozagrel Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.

Participant Flow:   Overall Study
    Edaravone     Ozagrel  
STARTED     199     202  
Safety Analysis Set     194     198  
COMPLETED     191     195  
NOT COMPLETED     8     7  
Lack of Efficacy                 3                 3  
Protocol Violation                 4                 4  
Nontreatment                 1                 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
Edaravone Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Ozagrel Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Total Total of all reporting groups

Baseline Measures
    Edaravone     Ozagrel     Total  
Number of Participants  
[units: participants]
  191     195     386  
Age, Customized  
[units: years]
     
birth-19 years     0     0     0  
20-64 years     64     58     122  
65- years     127     137     264  
Gender  
[units: participants]
     
Female     70     77     147  
Male     121     118     239  



  Outcome Measures
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1.  Primary:   the Rate of Patients With a Modified Rankin Scale Score of 0-1   [ Time Frame: 3 months ]

2.  Secondary:   Barthel Index Score   [ Time Frame: 3 months ]

3.  Secondary:   Baseline NIH Stroke Scale Score   [ Time Frame: Before treatment initiation ]

4.  Secondary:   NIH Stroke Scale Score at 14 Days   [ Time Frame: 14 days ]

5.  Secondary:   NIH Stroke Scale Score at 1 Month   [ Time Frame: 1 month ]

6.  Secondary:   NIH Stroke Scale Score at 3 Months   [ Time Frame: 3 months ]

7.  Secondary:   Japan Stroke Scale (Motor Function) Score at 14 Days   [ Time Frame: 14 days ]

8.  Secondary:   Japan Stroke Scale (Motor Function) Score at 1 Month   [ Time Frame: 1 month ]

9.  Secondary:   Japan Stroke Scale (Motor Function) Score at 3 Months   [ Time Frame: 3 months ]

10.  Secondary:   Modified Rankin Scale Score   [ Time Frame: 6 months ]


  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
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
e-mail: cti-inq-ml@ml.mt-pharma.co.jp


Publications of Results:

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00200356     History of Changes
Other Study ID Numbers: MCI186-13
Study First Received: September 12, 2005
Results First Received: September 13, 2012
Last Updated: December 9, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare