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

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Primary endpoints revised (2)v3 Show 5 more changesShow less
    • Interventions: alteplase (Drug) to Alteplase (Drug)
    • Eligibility criteria expanded, about 7 words
    • Publications: details revised at 1 of 2 entries
    • Study description shortened, about 1 word
    • Study title expanded, about 2 words
  3. Results first posted: Feb 24, 2012v2 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 100 to 103
    • Publications: 1 to 2
    • Study arms: 0 to 1
  4. 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.
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.
Trial Details
NCT Number NCT00147316
Lead Sponsor Tanabe Pharma Corporation
Collaborators: Kyowa Hakko Kogyo Co., Ltd.
Conditions
(from sponsor)		 Cerebral Infarction, Brain Ischemia
Related terms Brain Ischemia, Cerebral Infarction, Stroke
Enrollment 103 participants
Start Date
Study Completion (estimated)
Updated on ClinicalTrials.gov