A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute Stroke

NCT00073476

Last updated date
Study Location
Pfizer Investigational Site
La Mesa, California, 91942, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Stroke
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Treatment with t-PA (tissue plasminogen activator)


Premorbid modified rankin scale score of 2 or more

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StrokeA Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute Stroke
NCT00073476
  1. La Mesa, California
  2. Atlanta, Georgia
  3. Fort Wayne, Indiana
  4. Fort Wayne, Indiana
  5. Louisville,, Kentucky
  6. Louisville, Kentucky
  7. Salisbury, North Carolina
  8. Dayton, Ohio
  9. Dayton, Ohio
  10. Dayton, Ohio
  11. Dayton, Ohio
  12. Allentown, Pennsylvania
  13. Philadelphia, Pennsylvania
  14. Tartu,
  15. Bad Neustadt,
  16. Freiburg,
  17. Leipzig,
  18. Luebeck,
  19. Budapest,
  20. Gyor,
  21. Pavia,
  22. Perugia,
  23. Coimbra,
  24. Lisboa,
  25. Singapore,
  26. Singapore,
  27. Santiago de Compostela, Galicia
  28. Madrid,
  29. Madrid,
  30. Zaragoza,
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
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
 (submitted: June 20, 2006)
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
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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