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

StatusCompleted
PhasePhase 4
SponsorShionogi
Started

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Record History

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  1. Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 9 of 9 entries
    • Publications: details revised at 1 of 1 entry
  2. Lead sponsor: Tanabe Pharma Corporation to Shionogi
    • Primary completion date: Oct 31, 2006
    • Study completion date: Oct 2006 to Oct 31, 2006
    • Start date: Aug 2004 to Aug 31, 2004
    v9
  3. Re-verified, no change to tracked fieldsv8
  4. Results first posted: Jan 15, 2013v7 Show 4 more changesShow less
    • Interventions: Sodium Ozagrel (Drug), edaravone (Drug) to Edaravone (Drug), Sodium Ozagrel (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 5 to 9
    • Primary endpoint revised
  5. Study Status, Referencesv6
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  1. Primary endpoint revisedv5 Show 8 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: 401
    • Study sites: 1 to 0
    • Study completion date: Oct 2006
    • Interventions: edaravone (Drug) to Sodium Ozagrel (Drug), edaravone (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 4 to 5
    • Study arms: 0 to 2
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Recruiting to Active, Not Recruiting
    • Secondary endpoints revised (4)
    • Site details revised
    v3
  4. Eligibility criteria revisedv2
  1. Study First Submitted
  • 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.
Shionogi
45 trials monitored
See 2 trials at risk
Stroke
3,558 trials monitored
See 168 trials at risk
This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.
Trial Details
NCT Number NCT00200356
Lead Sponsor Shionogi
Conditions
(from sponsor)		 Cerebral Infarction
Related terms Cerebral Infarction
Enrollment 401 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov