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.
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
Treatment with t-PA (tissue plasminogen activator)
Premorbid modified rankin scale score of 2 or more
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute Stroke | |||
| Official Title ICMJE | 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. | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Stroke | |||
| Intervention ICMJE | Drug: traxiprodil (CP-101,606) | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Enrollment ICMJE | 300 | |||
| Original Enrollment ICMJE | Not Provided | |||
| Study Completion Date ICMJE | February 2005 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | 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 | |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 40 Years to 90 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Estonia, Germany, Hungary, Italy, Portugal, Singapore, Spain, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00073476 | |||
| Other Study ID Numbers ICMJE | A1611005 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2006 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
