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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00073476
Recruitment Status : Terminated
First Posted : November 24, 2003
Last Update Posted : June 22, 2006
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Stroke Drug: traxiprodil (CP-101,606) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : September 2003
Study Completion Date : February 2005



Primary Outcome Measures :
  1. No or minimal neurological deficit at last visit
  2. Marked neurological improvement at last visit

Secondary Outcome Measures :
  1. Modified Rankin scale at last visit
  2. Mortality
  3. Safety assessments


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073476


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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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ClinicalTrials.gov Identifier: NCT00073476     History of Changes
Other Study ID Numbers: A1611005
First Posted: November 24, 2003    Key Record Dates
Last Update Posted: June 22, 2006
Last Verified: June 2006

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases