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

Tracking Information

First Received Date ^ICMJE

November 21, 2003

Last Updated Date

June 20, 2006

Start Date ^ICMJE

September 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00073476 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Modified Rankin scale at last visit
Mortality
Safety assessments

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Stroke

Intervention ^ICMJE

Drug: traxiprodil (CP-101,606)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

300

Completion Date

February 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00073476

Responsible Party

Study ID Numbers ^ICMJE

A1611005

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP