Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Salisbury, North Carolina 28144


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.


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


Study is Available At:


Original ID:

A1611005


NCT ID:

NCT00073476


Secondary ID:


Study Acronym:


Brief Title:

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


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.


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:September 2003
Completion Date:February 2005
Verification Date:June 2006
Last Changed Date:June 20, 2006
First Received Date:November 21, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:No or minimal neurological deficit at last visit
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Marked neurological improvement at last visit
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Modified Rankin scale at last visit
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mortality
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety assessments
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:traxiprodil (CP-101,606)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.