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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00073476 |
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 |
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
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | A1611005 |
Study First Received: | November 21, 2003 |
Last Updated: | June 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00073476 |
Health Authority: | United States: Food and Drug Administration |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases |
Ischemia Brain Diseases Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |