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 |
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.
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.
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
33
sites
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Spaulding Rehabilitation Hospital At Spaulding Rehabiliation Hospital Boston, our unique approach to therapy includes use...
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Hershey, Pennsylvania 17033
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Barnes Jewish Hospital Barnes-Jewish Hospital at Washington University Medical Center is the largest hospital in...
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