drugset / Trial / NCT04479449

Efficacy and Safety of SP-8203 in Patients With Ischemic Stroke Requiring rtPA

NCT04479449 ↗

Phase 2 Completed 178 enrolled Shin Poong Pharmaceutical Co. Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This clinical trial is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (Otaplimastat) and recombinant tissue Plasminogen Activator (rtPA) standard of care. In this clinical trial, rtPA will be injected intravenously using an infusion device. If reperfusion is not occur in spite of rtPA therapy, endovascular therapy can be performed.

Timeline

Start
2019-03-18
Primary completion
2020-10-19
Completion
2020-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject OTAPLIMASTAT Small molecule 40 mg Intravenous

Indications