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

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

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