Status:

TERMINATED

Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke

Lead Sponsor:

Pfizer

Conditions:

Ischemic Stroke

Eligibility:

All Genders

18-85 years

Phase:

PHASE2

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following multiple dose administration to subjects with ischemic stroke. The study will also evaluate the efficacy o...

Detailed Description

The interim analysis for the POC study A9541004 demonstrated futility, and the study was stopped on the 6th of November 2013. There were no signals of serious safety concern.

Eligibility Criteria

Inclusion

  • Diagnosis of ischemic stroke with an onset within 72 hours prior to start of study agent administration, male or female.
  • Supratentorial ischemic stroke involving the cortex documented by neurological exam and confirmed by MRI.
  • Stroke involving upper extremity.
  • Subjects who received thrombolytic therapy may be enrolled and the use of antiplatelet is acceptable.

Exclusion

  • Any other severe acute or chronic medical or psychiatric condition besides the stroke.
  • Women of child bearing potential.
  • Uncontrolled hypertension.

Key Trial Info

Start Date :

December 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

181 Patients enrolled

Trial Details

Trial ID

NCT01208233

Start Date

December 1 2010

End Date

December 1 2013

Last Update

February 19 2016

Active Locations (70)

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Page 1 of 18 (70 locations)

1

Spain Rehabilitation Center

Birmingham, Alabama, United States, 35233

2

The Kirklin Clinic

Birmingham, Alabama, United States, 35233

3

University Hospital

Birmingham, Alabama, United States, 35294-3280

4

Broward Health North

Deerfield Beach, Florida, United States, 33064