NCT02787278View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 5, 2016

Primary Completion Date

May 30, 2017

Study Completion Date

August 22, 2017

Conditions
Ischemic Stroke
Interventions
DRUG

SP-8203 High dose

High-dose group: 160mg will be intravenously administered as 80mg/dose twice daily (intervals of 12 hours).

DRUG

SP-8203 Low dose

Low dose group: 80mg will be intravenously administered as 40mg/dose twice daily (intervals of 12 hours).

DRUG

Placebo

Same dosage of SP8203. Placebo will be intravenously administered twice daily (intervals of 12 hours)

Trial Locations (8)

Unknown

Pusan National University Hospital, Busan

Kyungpook National University Hospital, Daegu

Myongji Hospital, Gyeonggi-do

Inje University Busan Paik Hospital, Pusan

Asan Medical Center, University of Ulsan, Seoul

Korea University Guro Hospital, Seoul

KyungHee University Medical Center, Seoul

Soonchunhyang University Hospital, Seoul

All Listed Sponsors
lead

Shin Poong Pharmaceutical Co. Ltd.

INDUSTRY

NCT02787278 - Safety and Efficacy of Two Doses of SP-8203 in Patients With Ischemic Stroke Requiring rtPA | Biotech Hunter | Biotech Hunter