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Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care
Sponsor: Shin Poong Pharmaceutical Co. Ltd.
Summary
This clinical study is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (otaplimastat) and thrombolytic standard of care in acute ischemic stroke patient. As a standard of care, thrombolytic therapy (for instance, recombinant tissue plasminogen activator) will be administered. When reperfusion is not achieved in spite of thrombolytic therapy, endovascular therapy can be performed.
Official title: A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase III Clinical Study to Evaluate Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Requiring Thrombolytic Therapy as Standard of Care
Key Details
Gender
All
Age Range
19 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
852
Start Date
2025-02-14
Completion Date
2027-03-30
Last Updated
2025-03-07
Healthy Volunteers
No
Conditions
Interventions
SP-8203
SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours)
Placebo
Placebo will be intravenously administered twice daily (intervals of 12 hours)
Locations (2)
Dong-A University Hospital
Busan, South Korea
Ulsan University Hospital
Ulsan, South Korea