CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 401 enrolled
Drug / intervention
Edaravone +1 moredrug
Likely dose
Edaravone 30 mg IV twice daily over 30 minutes OR Sodium Ozagrel 80 mg IV twice daily over 2 hoursAI-extracted
Key inclusion· 4
  • ✓Drug treatment initiated within 24 hours after stroke onset
  • ✓Consciousness level between 0 (alert) and 3 (unable to recall name and date) on Japan Coma Scale
  • ✓Motor dysfunction of upper and/or lower extremities
  • ✓Age ≥20 years at informed consent
Key exclusion· 13
  • ✕Serum creatinine >1.5 mg/dL
  • ✕Embolic infarction
  • ✕Intracranial hemorrhage
  • ✕Large infarction with severe consciousness impairment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00200356
NCT00200356Phase 4Completed
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Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke

Tanabe Pharma Corporation·interventional·Posted Sep 20, 2005·Updated Jan 7, 2026

In Brief

A Phase 4 clinical trial evaluating Edaravone and Sodium Ozagrel for Cerebral Infarction. Completed, enrolled 401 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebral Infarction
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartAug 1, 2004
Study CompletionOct 1, 2006
TodayJul 2, 2026
Posted 20.8 years ago

Interventions

Edaravonedrug

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

Sodium Ozagreldrug

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