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

Amendment history

1. Jul 2, 2026

   Notable

   Lead sponsor: Tanabe Pharma Corporation to Shionogi

   Primary completion date: Oct 31, 2006; Completion date: Oct 2006 to Oct 31, 2006; Start date: Aug 2004 to Aug 31, 2004

   Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations · v9

2. Dec 15, 2025

   Minor

   Study Status, More Information

   Re-verified, no change to tracked fields

   v8

3. Dec 9, 2012

   Notable

   Results first posted: Jan 15, 2013

   Interventions: Sodium Ozagrel (Drug), edaravone (Drug) to Edaravone (Drug), Sodium Ozagrel (Drug); Eligibility criteria revised; Secondary endpoints: 5 to 9; and 1 more

   Show all 5 changes in this update

   • Notable Results first posted: Jan 15, 2013
   • Minor Interventions: Sodium Ozagrel (Drug), edaravone (Drug) to Edaravone (Drug), Sodium Ozagrel (Drug)
   • Minor Eligibility criteria revised
     Show what changed

     [...] um creatinine of >1.5 mg/dL Embolic infarction Intracranial hemorrhagehaemorrhage Large infarction with severe consciousness Transient ischem [...]
   • Minor Secondary endpoints: 5 to 9
     Show what changed

     Barthel Index scoreScore Baseline NIH Stroke Scale Score NIH Stroke Scale scoreScore at 14 Days NIH Stroke Scale Score at 1 Month NIH Stroke Scale Score at 3 Months Japan Stroke Scale (Motor Function) scoreScore at 14 Days modifiedJapan Stroke Scale (Motor Function) Score at 1 Month Japan Stroke Scale (Motor Function) Score at 3 Months Modified Rankin Scale score SafetyScore
   • Minor Primary endpoint revised
     Show what changed

     the rateRate of patientsPatients withWith a modifiedModified Rankin Scale scoreScore of 0-1

   Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information · v7

4. Nov 5, 2009

   Minor

   Study Status, References

   v6

5. Dec 26, 2007

   Notable

   Primary endpoint revised

   Trial status: Active, Not Recruiting to Completed; Enrollment target: 401; Study sites: 1 to 0; and 5 more

   Show all 9 changes in this update

   • Notable Primary endpoint revised
     Show what changed

     the rate of patients with a modified Rankin Scale score of 0-1 at 3months
   • Minor Trial status: Active, Not Recruiting to Completed
   • Minor Enrollment target: 401
   • Minor Study sites: 1 to 0
   • Minor Completion date: Oct 2006
   • Minor Interventions: edaravone (Drug) to Sodium Ozagrel (Drug), edaravone (Drug)
   • Minor Eligibility criteria revised
     Show what changed

     [...] ravone and sodium ozagrel) after stroke onset Patients were recievereceive surgical treatment or intravascular treatment With severe c [...]
   • Minor Secondary endpoints: 4 to 5
     Show what changed

     Barthel Index score at 3months NIH Stroke Scale score at 14days, 1months and 3months Japan Stroke Scale (Motor Function) score at 14days, 1months and 3months modified Rankin Scale score at 6months Safety
   • Minor Study arms: 0 to 2

   Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations · v5

9. Sep 12, 2005

   Minor

   Study First Submitted

• Stopped: an ongoing trial was terminated, suspended or withdrawn.
• Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
• Minor: routine progress and housekeeping, such as sites added or enrollment closed.