NCT00073476

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2 stroke

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_2 stroke

Geographic Reach
7 countries

28 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

June 22, 2006

Status Verified

June 1, 2006

First QC Date

November 21, 2003

Last Update Submit

June 20, 2006

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • No or minimal neurological deficit at last visit

  • Marked neurological improvement at last visit

Secondary Outcomes (3)

  • Modified Rankin scale at last visit

  • Mortality

  • Safety assessments

Interventions

traxiprodil (CP-101,606)DRUG

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Treatment with t-PA (tissue plasminogen activator)
  • Premorbid modified rankin scale score of 2 or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Pfizer Investigational Site

La Mesa, California, 91942, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30342, United States

Location

Pfizer Investigational Site

Fort Wayne, Indiana, 46804, United States

Location

Pfizer Investigational Site

Fort Wayne, Indiana, 46805, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40202, United States

Location

Pfizer Investigational Site

Salisbury, North Carolina, 28144, United States

Location

Pfizer Investigational Site

Dayton, Ohio, 45406, United States

Location

Pfizer Investigational Site

Dayton, Ohio, 45408, United States

Location

Pfizer Investigational Site

Dayton, Ohio, 45409, United States

Location

Pfizer Investigational Site

Dayton, Ohio, 45415, United States

Location

Pfizer Investigational Site

Allentown, Pennsylvania, 18103, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19141, United States

Location

Pfizer Investigational Site

Tartu, 51014, Estonia

Location

Pfizer Investigational Site

Bad Neustadt an der Saale, 97616, Germany

Location

Pfizer Investigational Site

Freiburg im Breisgau, 79106, Germany

Location

Pfizer Investigational Site

Leipzig, 04103, Germany

Location

Pfizer Investigational Site

Lübeck, 23538, Germany

Location

Pfizer Investigational Site

Budapest, H-1021, Hungary

Location

Pfizer Investigational Site

Győr, H-9023, Hungary

Location

Pfizer Investigational Site

Pavia, 27100, Italy

Location

Pfizer Investigational Site

Perugia, 06126, Italy

Location

Pfizer Investigational Site

Coimbra, Codex 3049, Portugal

Location

Pfizer Investigational Site

Lisbon, 1600, Portugal

Location

Pfizer Investigational Site

Singapore, 169608, Singapore

Location

Pfizer Investigational Site

Singapore, 308433, Singapore

Location

Pfizer Investigational Site

Santiago de Compostela, Galicia, 15706, Spain

Location

Pfizer Investigational Site

Madrid, 28007, Spain

Location

Pfizer Investigational Site

Madrid, 28034, Spain

Location

Pfizer Investigational Site

Zaragoza, 50009, Spain

Location

Related Links

MeSH Terms

Conditions

Stroke

Interventions

traxoprodil mesylate

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 21, 2003

First Posted

November 24, 2003

Study Start

September 1, 2003

Study Completion

February 1, 2005

Last Updated

June 22, 2006

Record last verified: 2006-06

Locations

US(12)ES(4)SG(2)HU(2)PT(2)IT(2)DE(4)