PG2 Injection 500 mg in Acute Stroke Study (Pass)

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

Timeline

Start

2012-06

Primary completion

2015-10

Completion

2015-10

Drugs

Indications