Overview

PG2 Injection 500 mg in Acute Stroke Study (Pass)

Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with an acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90. The secondary objectives are as follows: - To evaluate the efficacy of PG2 Injection 500 mg versus placebo as determined by Barthel Index (BI) score at Day 90. - To evaluate the efficacy of PG2 Injection 500 mg in reducing the risk of recurrent stroke, cardiovascular events and death of all causes. - To evaluate the safety of PG2 Injection 500 mg treatment
Phase:
Phase 2
Details
Lead Sponsor:
China Medical University Hospital
Collaborators:
Changhua Christian Hospital
Cheng Hsin Rehabilitation Medical Center
Chung Shan Medical University
En Chu Kong Hospital
Kaohsiung Medical University
Kaohsiung Veterans General Hospital.
Kuang Tien General Hospital
National Cheng-Kung University Hospital
National Taiwan University Hospital
Shin Kong Wu Ho-Su Memorial Hospital
Taipei Medical University Shuang Ho Hospital
Taipei Medical University WanFang Hospital
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital