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RECRUITING
NCT06660719
PHASE3

Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care

Sponsor: Shin Poong Pharmaceutical Co. Ltd.

View on ClinicalTrials.gov

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

DRUG

SP-8203

SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours)

DRUG

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