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

NCT02787278 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-07-21

No results posted yet for this study

Summary

The current study aims to evaluate the safety of SP-8203, designing in two stages (stage-1, stage-2) to evaluate the safety and efficacy of the combination therapy of SP-8203 and rtPA for the occurrence of cerebral hemorrhage in patients with acute ischemic stroke receiving rtPA standard of care.

Conditions

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)

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Jong Sung Kim, MD, Phd · Department of Neurology, Asan Medical Center, Seoul, South Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-05
Primary Completion
2017-05-30
Completion
2017-08-22

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02787278 on ClinicalTrials.gov