Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke

Completed

Phase 3 Results

Summary of Purpose

Based on previous studies comparing Duteplase[a recombinant tissue plasminogen activator (rt-PA) very similar to alteplase] doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 29 February 2012.

1 Apr 2002 5 Sep 2005 Unavailable 1 Sep 2003 1 Feb 2012 19 Jan 2012
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Contacts

Not available