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

NCT ID: NCT00073476

Last Updated: 2006-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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traxiprodil (CP-101,606)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

La Mesa, California, United States

Site Status

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Atlanta, Georgia, United States

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Fort Wayne, Indiana, United States

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Fort Wayne, Indiana, United States

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Louisville, Kentucky, United States

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Salisbury, North Carolina, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Tartu, , Estonia

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Bad Neustadt an der Saale, , Germany

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Freiburg im Breisgau, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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Budapest, , Hungary

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Győr, , Hungary

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Pavia, , Italy

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Perugia, , Italy

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Coimbra, , Portugal

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Lisbon, , Portugal

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Singapore, , Singapore

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Singapore, , Singapore

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Santiago de Compostela, Galicia, Spain

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Madrid, , Spain

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Madrid, , Spain

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Zaragoza, , Spain

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Countries

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United States Estonia Germany Hungary Italy Portugal Singapore Spain

Related Links

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Other Identifiers

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A1611005

Identifier Type: -

Identifier Source: org_study_id