A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute Stroke
Primary Purpose
Stroke
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
traxiprodil (CP-101,606)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
No or minimal neurological deficit at last visit
Marked neurological improvement at last visit
Secondary Outcome Measures
Modified Rankin scale at last visit
Mortality
Safety assessments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00073476
Brief Title
A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute Stroke
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Terminated
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
traxiprodil (CP-101,606)
Primary Outcome Measure Information:
Title
No or minimal neurological deficit at last visit
Title
Marked neurological improvement at last visit
Secondary Outcome Measure Information:
Title
Modified Rankin scale at last visit
Title
Mortality
Title
Safety assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville,
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Pfizer Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Pfizer Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Pfizer Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Bad Neustadt
ZIP/Postal Code
97616
Country
Germany
Facility Name
Pfizer Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Pfizer Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Pfizer Investigational Site
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
H-1021
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Gyor
ZIP/Postal Code
H-9023
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Perugia
ZIP/Postal Code
06126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Coimbra
ZIP/Postal Code
Codex 3049
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1600
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Pfizer Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1611005&StudyName=A+Study+to+Evaluate+the+Efficacy+and+Safety+of++CP%2D101%2C606+in+Subjects+With+an+Acute+Stroke+
Description
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Learn more about this trial
A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute Stroke
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