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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00073476 |
Purpose
The purpose of this study is to determine whether a new research medication is effective and safe for the treatment of acute stroke when given within 6 hours of the onset of stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Drug: traxiprodil (CP-101,606) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a 72-Hour Infusion of CP-101,606 in Subjects With Acute Ischemic Stroke. |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | February 2005 |
Eligibility| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Males & females age 40-90 years
Enrolled in study within 6 hours of onset of stroke symptoms
Willing to sign informed consent form
No significant disabilities prior to stroke
Exclusion Criteria:
Treatment with t-PA (tissue plasminogen activator)
Premorbid modified rankin scale score of 2 or more
Contacts and Locations
Hide Study Locations| United States, California | |
| Pfizer Investigational Site | |
| La Mesa, California, United States, 91942 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Fort Wayne, Indiana, United States, 46804 | |
| Pfizer Investigational Site | |
| Fort Wayne, Indiana, United States, 46805 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40202 | |
| Pfizer Investigational Site | |
| Louisville,, Kentucky, United States, 40202 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Salisbury, North Carolina, United States, 28144 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45408 | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45409 | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45415 | |
| Pfizer Investigational Site | |
| DAYTON, Ohio, United States, 45406 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Pfizer Investigational Site | |
| Allentown, Pennsylvania, United States, 18103 | |
| Estonia | |
| Pfizer Investigational Site | |
| Tartu, Estonia, 51014 | |
| Germany | |
| Pfizer Investigational Site | |
| Leipzig, Germany, 04103 | |
| Pfizer Investigational Site | |
| Bad Neustadt, Germany, 97616 | |
| Pfizer Investigational Site | |
| Freiburg, Germany, 79106 | |
| Pfizer Investigational Site | |
| Luebeck, Germany, 23538 | |
| Hungary | |
| Pfizer Investigational Site | |
| BUDAPEST, Hungary, H-1021 | |
| Pfizer Investigational Site | |
| GYOR, Hungary, H-9023 | |
| Italy | |
| Pfizer Investigational Site | |
| Perugia, Italy, 06126 | |
| Pfizer Investigational Site | |
| Pavia, Italy, 27100 | |
| Portugal | |
| Pfizer Investigational Site | |
| Lisboa, Portugal, 1600 | |
| Pfizer Investigational Site | |
| Coimbra, Portugal, Codex 3049 | |
| Singapore | |
| Pfizer Investigational Site | |
| SINGAPORE, Singapore, 169608 | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 308433 | |
| Spain | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28007 | |
| Pfizer Investigational Site | |
| Zaragoza, Spain, 50009 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28034 | |
| Spain, GALICIA | |
| Pfizer Investigational Site | |
| Santiago de Compostela, GALICIA, Spain, 15706 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Study ID Numbers: | A1611005 |
| Study First Received: | November 21, 2003 |
| Last Updated: | June 20, 2006 |
| ClinicalTrials.gov Identifier: | NCT00073476 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Brain Ischemia |
Central Nervous System Diseases Cardiovascular Diseases Brain Infarction Brain Diseases Cerebrovascular Disorders |
