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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT01208233

Run by

Pfizer

People needed

181

Starts

2010-12-01

Expected to finish

2013-12-01

Last updated by the study team

2016-02-19

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• The Kirklin Clinic — Birmingham, Alabama, United States
• University Hospital — Birmingham, Alabama, United States
• Broward Health North — Deerfield Beach, Florida, United States
• Neurologic Consultant, P.A. — Fort Lauderdale, Florida, United States
• Fawcett Memorial Hospital — Port Charlotte, Florida, United States
• Neurostudies, Inc. — Port Charlotte, Florida, United States
• Jagdish Sidhpura M.D. — Columbus, Georgia, United States
• Jose Canedo, M.D., West Georgia Neurology — Columbus, Georgia, United States
• St. Francis Hospital — Columbus, Georgia, United States
• Muscogee Manor & Rehabilitation Center — Columbus, Georgia, United States
• Medical Research & Health Education Foundation, Inc. — Columbus, Georgia, United States
• Parkview Hospital Randallia — Fort Wayne, Indiana, United States
• Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
• Parkview Regional Medical Center — Fort Wayne, Indiana, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• Norwood Nursing Center — Huntington, Indiana, United States
• Massachusetts General Hospital/Department of Neurology — Boston, Massachusetts, United States
• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Rehabilitation Institute of St. Louis — St Louis, Missouri, United States
• UNC HealthCare — Chapel Hill, North Carolina, United States
• UNC Department of Neurology Stroke Division — Chapel Hill, North Carolina, United States
• Investigational Drug Services at OU Medical Center — Oklahoma City, Oklahoma, United States
• Spain Rehabilitation Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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