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



Status:Terminated
Conditions:Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:December 2010
End Date:December 2013

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A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of Pf-03049423 In Subjects With Ischemic Stroke

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 of PF-03049423, relative to placebo, in subjects with ischemic stroke
following 90 days of therapy. The study will also explore the relationship between
PF-03049423 concentration and blood pressure.

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.

Inclusion Criteria:

- 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 Criteria:

- Any other severe acute or chronic medical or psychiatric condition besides the
stroke.

- Women of child bearing potential.

- Uncontrolled hypertension.
We found this trial at
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Birmingham, Alabama 35294
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
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Birmingham, Alabama 35233
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Birmingham, Alabama 35233
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300 1st Avenue
Boston, Massachusetts 02129
617-952-5000
Spaulding Rehabilitation Hospital At Spaulding Rehabiliation Hospital Boston, our unique approach to therapy includes use...
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Chapel Hill, North Carolina 27599
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Chapel Hill, North Carolina 27599
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Columbus, Georgia 31901
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Columbus, Georgia 31904
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Columbus, Georgia 31907
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Deerfield Beach, Florida 33064
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Fort Lauderdale, Florida 33308
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2200 Randallia Drive
Fort Wayne, Indiana 46805
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Fort Wayne, Indiana 46805
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Fort Wayne, Indiana 46845
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Fort Wayne, Indiana 46805
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Houston, Texas 77030
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Hummelstown, Pennsylvania 17036
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Huntington, Indiana 46750
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Oklahoma City, Oklahoma 73104
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Oklahoma City, Oklahoma 73104
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Oklahoma City, Oklahoma 73104
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Pleven,
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Port Charlotte, Florida 33952
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Port Charlotte, Florida 33952
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1 Barnes Jewish Hospital Plaza
St. Louis, Missouri 63110
(314) 747-3000
Barnes Jewish Hospital Barnes-Jewish Hospital at Washington University Medical Center is the largest hospital in...
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