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

Conditions

• Acute Stroke

Interventions

DRUG

PG2

STUDY DRUG DOSAGE:IV infusion of PG2 Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg PG2 Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5\~3.5 hrs. The same dose of PG2 Injection 500 mg will be repeated daily for the subsequent 2 days. ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days

DRUG

placebo

STUDY DRUG DOSAGE: IV infusion of Placebo Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg Placebo Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5\~3.5 hrs. The same dose of Placebo Injection 500 mg will be repeated daily for the subsequent 2 days. ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days

Sponsors & Collaborators

• National Taiwan University Hospital

  collaborator OTHER

• Shin Kong Wu Ho-Su Memorial Hospital

  collaborator OTHER

• Tri-Service General Hospital

  collaborator OTHER

• Changhua Christian Hospital

  collaborator OTHER

• National Cheng-Kung University Hospital

  collaborator OTHER

• Kaohsiung Medical University

  collaborator OTHER

• En Chu Kong Hospital

  collaborator OTHER

• Kuang Tien General Hospital

  collaborator OTHER

• Chung Shan Medical University

  collaborator OTHER

• Taipei Veterans General Hospital, Taiwan

  collaborator OTHER_GOV

• Kaohsiung Veterans General Hospital.

  collaborator OTHER

• Taipei Medical University Shuang Ho Hospital

  collaborator OTHER

• Cheng Hsin Rehabilitation Medical Center

  collaborator OTHER

• Taipei Medical University WanFang Hospital

  collaborator OTHER

• China Medical University Hospital

  lead OTHER

Principal Investigators

• Chung Y. Hsu, PhD · China Medical University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2015-10-31

Completion

2015-10-31

Countries

• Taiwan

Study Locations