ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute Stroke

This study has been terminated.

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00073476
  Purpose

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.


Condition Intervention Phase
Stroke
Drug: traxiprodil (CP-101,606)
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Pfizer:

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

Estimated Enrollment:   300
Study Start Date:   September 2003
Estimated Study Completion Date:   February 2005

  Eligibility
Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073476

Show 30 study locations  Show 30 Study Locations

Sponsors and Collaborators
Pfizer

Investigators
Study Director:     Pfizer CT.gov Call Center     Pfizer    
  More Information

To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   A1611005
First Received:   November 21, 2003
Last Updated:   June 20, 2006
ClinicalTrials.gov Identifier:   NCT00073476
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2008




Links to all studies - primarily for crawlers