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

June 20, 2006 updated by: Pfizer

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tartu, Estonia, 51014
        • Pfizer Investigational Site
  • Germany
      • Bad Neustadt, Germany, 97616
        • Pfizer Investigational Site
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Leipzig, Germany, 04103
        • Pfizer Investigational Site
      • Luebeck, Germany, 23538
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, H-1021
        • Pfizer Investigational Site
      • Gyor, Hungary, H-9023
        • Pfizer Investigational Site
  • Italy
      • Pavia, Italy, 27100
        • Pfizer Investigational Site
      • Perugia, Italy, 06126
        • Pfizer Investigational Site
  • Portugal
      • Coimbra, Portugal, Codex 3049
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1600
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 169608
        • Pfizer Investigational Site
      • Singapore, Singapore, 308433
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Madrid, Spain, 28007
        • Pfizer Investigational Site
      • Zaragoza, Spain, 50009
        • Pfizer Investigational Site
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Pfizer Investigational Site
  • United States
    • California
      • La Mesa, California, United States, 91942
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Pfizer Investigational Site
      • Fort Wayne, Indiana, United States, 46804
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
      • Louisville,, Kentucky, United States, 40202
        • Pfizer Investigational Site
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Pfizer Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45406
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45408
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45409
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45415
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19141
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
No or minimal neurological deficit at last visit
Marked neurological improvement at last visit

Secondary Outcome Measures

Outcome Measure
Mortality
Safety assessments
Modified Rankin scale at last visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

February 1, 2005

Study Registration Dates

First Submitted

November 21, 2003

First Submitted That Met QC Criteria

November 21, 2003

First Posted (Estimate)

November 24, 2003

Study Record Updates

Last Update Posted (Estimate)

June 22, 2006

Last Update Submitted That Met QC Criteria

June 20, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1611005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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