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NCT00073476 Clinical Trial

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

Stroke Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00073476
Other study ID # A1611005
Secondary ID
Status Terminated
Phase Phase 2
First received November 21, 2003
Last updated June 20, 2006
Start date September 2003
Est. completion date February 2005

Study information
Verified date June 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 300
Est. completion date February 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 90 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• traxiprodil (CP-101,606)

Locations
Country Name City State
Estonia Pfizer Investigational Site Tartu
Germany Pfizer Investigational Site Bad Neustadt
Germany Pfizer Investigational Site Freiburg
Germany Pfizer Investigational Site Leipzig
Germany Pfizer Investigational Site Luebeck
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Gyor
Italy Pfizer Investigational Site Pavia
Italy Pfizer Investigational Site Perugia
Portugal Pfizer Investigational Site Coimbra
Portugal Pfizer Investigational Site Lisboa
Singapore Pfizer Investigational Site Singapore
Singapore Pfizer Investigational Site Singapore
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Santiago de Compostela Galicia
Spain Pfizer Investigational Site Zaragoza
United States Pfizer Investigational Site Allentown Pennsylvania
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Fort Wayne Indiana
United States Pfizer Investigational Site Fort Wayne Indiana
United States Pfizer Investigational Site La Mesa California
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Louisville, Kentucky
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Salisbury North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Estonia,  Germany,  Hungary,  Italy,  Portugal,  Singapore,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary No or minimal neurological deficit at last visit
Primary Marked neurological improvement at last visit
Secondary Modified Rankin scale at last visit
Secondary Mortality
Secondary Safety assessments
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