A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)

March 31, 2006 updated by: Astellas Pharma Inc

A Multicenter, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Neurologic Function and Disability in Patients With Acute Ischemic Stroke Given Tissue Plasminogen Activator Plus YM872 or Tissue Plasminogen Activator Plus Placebo

The purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or placebo, is administered prior to the completion of the t-PA administration. The clinical effects of YM872 in addition to t-PA will be determined by assessing neurological function and disability scores at follow up visits through Day 90 of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • Universitätsklinik allgemeines Krankenhaus der Stadt Wien
  • Belgium
      • Leuven, Belgium
        • Dienst Neurologie UZ Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Foothills Medical Centre
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • British Columbia
      • Penticton, British Columbia, Canada
        • Penticton Regional Hospital
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
      • Victoria, British Columbia, Canada
        • Victoria General Hospital
      • Victoria, British Columbia, Canada
        • Royal Jubilee Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada
        • Charles Lemoyne Hospital
      • Montreal, Quebec, Canada
        • Notre-Dame Hospital
      • Trois Rivers, Quebec, Canada
        • Pavillion St Joseph
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Royal University Hospital
  • Germany
      • Aachen, Germany
        • Universitätsklinikum Aachen, Neurologische Klinik
      • Essen, Germany
        • University Essen
      • Freiburg, Germany
        • Neurologische Universitätsklinik
      • Hamburg-Eppendorf, Germany
        • Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
      • Hanover, Germany
        • Neurology Klinik Klinikum Hanover
      • Jena, Germany
        • Friedrich-Schiller-University
      • Köln, Germany
        • Universität zu Köln klinik und poliklinik fur neurology
      • Leipzig, Germany
        • Universitatsklinikum Leipzig
      • Mainz, Germany
        • Universitatsklinik Mainz
      • Munchen, Germany
        • Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
      • Recklinghausen, Germany
        • Neurologische Klinik Knappschafts - krankenhause
      • Weisbaden, Germany
        • Neurologisch Psychiayrische Klinik
  • United States
    • Alabama
      • Mobile, Alabama, United States
        • University of South Alabama Stroke Center
    • Arizona
      • Phoenix, Arizona, United States
        • Good Samaritan Hospital
      • Tucson, Arizona, United States
        • University of Arizona
    • California
      • Berkeley, California, United States
        • East Bay Region Associates in Neurology
      • Burbank, California, United States
        • Providence St. Joseph's Medical Center
      • Carmichael, California, United States
        • Mercy San Juan Hospital
      • Davis, California, United States
        • University of California Davis Medical Center
      • Encinitas, California, United States
        • Scripps Memorial Hospital
      • La Mesa, California, United States
        • Grossmont Hospital
      • Los Angeles, California, United States
        • UCLA Medical Center
      • Oceanside, California, United States
        • Tri-City Medical Center
      • Palo Alto, California, United States
        • Stanford University Medical Center
      • Sacramento, California, United States
        • Mercy General Hospital
      • San Diego, California, United States
        • University of California at San Diego
      • San Diego, California, United States
        • Scripps Mercy Hospital
      • San Jose, California, United States
        • Good Samaritan Hospital
      • Santa Monica, California, United States
        • UCLA Medical Center - Santa Monica
      • Walnut Creek, California, United States
        • John Muir Medical Center
      • Walnut Creek, California, United States
        • Mt Diablo Medical Center
    • Colorado
      • Englewood, Colorado, United States
        • Colorado Neurological Institute
    • Connecticut
      • Bridgeport, Connecticut, United States
        • Bridgeport Hospital
    • Florida
      • Atlantis, Florida, United States
        • Columbia JFK Hospital
      • Boynton Beach, Florida, United States
        • Bethesda Memorial Hospital
      • Lakeland, Florida, United States
        • Lakeland Regional Medical Center
      • Melbourne, Florida, United States
        • Holmes Regional Medical Center
      • Panama City, Florida, United States
        • Bay Medical Center
      • Tampa, Florida, United States
        • Tampa General Hospital
      • Tampa, Florida, United States
        • St Joseph's Hospital
    • Georgia
      • Columbus, Georgia, United States
        • St Francis Hospital
      • Decatur, Georgia, United States
        • DNA Research (Dekalb Medical Center)
      • Savannah, Georgia, United States
        • Candler Hospital
      • Savannah, Georgia, United States
        • St Joseph Hospital
    • Hawaii
      • Honolulu, Hawaii, United States
        • Queen's Medical Center
    • Illinois
      • Peoria, Illinois, United States
        • OSF St. Francis Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States
        • Parkview Hospital
      • Indianapolis, Indiana, United States
        • Methodist Hospital
    • Kentucky
      • Louisville, Kentucky, United States
        • Louisville Neuroscience Research Center
    • Louisiana
      • Marrero, Louisiana, United States
        • Culicchia Neurology Clinic, LLP
    • Maryland
      • Baltimore, Maryland, United States
        • University of Maryland Medical System
    • Massachusetts
      • Boston, Massachusetts, United States
        • New England Medical Center
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States
        • St John's Hospital
      • East Lansing, Michigan, United States
        • Michigan State University
      • Royal Oak, Michigan, United States
        • William Beaumont Hospital
      • Traverse City, Michigan, United States
        • Northern Michigan Neurology
      • Warren, Michigan, United States
        • Bi-County Hospital
    • Missouri
      • Kansas City, Missouri, United States
        • Research Medical Center
    • Montana
      • Great Falls, Montana, United States
        • Advanced Neurology Specialists (Benefis Healthcare Hospital)
    • Nevada
      • Reno, Nevada, United States
        • Washoe Comprehensive Stroke Center
    • New Jersey
      • Edison, New Jersey, United States
        • JFK Medical Center
      • Plainfield, New Jersey, United States
        • Muhlenberg Regional Medical Center
      • Ridgewood, New Jersey, United States
        • Neurology Group of Bergen County (Valley Hospital)
    • New Mexico
      • Albuquerque, New Mexico, United States
        • University of New Mexico Hospital
      • Albuquerque, New Mexico, United States
        • VA Medical Center
    • New York
      • Albany, New York, United States
        • Albany Medical Center
      • Buffalo, New York, United States
        • Buffalo General Hospital
      • Manhasset, New York, United States
        • North Shore University Hospital
      • New Hyde Park, New York, United States
        • Long Island Jewish Medical Center
      • New York, New York, United States
        • Columbia Presbyterian Medical Center
      • New York, New York, United States
        • St. Luke's Hospital
      • New York, New York, United States
        • Roosevelt hospital
      • Rochester, New York, United States
        • Rochester General Hospital
      • Schenectady, New York, United States
        • Ellis Hospital
      • Stony Brook, New York, United States
        • Stony Brook Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Forsyth Medical Center
      • Winston-Salem, North Carolina, United States
        • Rowan Regional Medical Center
    • Ohio
      • Akron, Ohio, United States
        • Akron General Medical Center
      • Cleveland, Ohio, United States
        • MetroHealth Medical Center
      • Columbus, Ohio, United States
        • Riverside Methodist Hospital
      • Toledo, Ohio, United States
        • Medical College of Ohio
      • Youngstown, Ohio, United States
        • St. Elizabeth Health Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • LeHigh Valley Hospital
      • Danville, Pennsylvania, United States
        • Geisinger Medical Center
      • Greensburg, Pennsylvania, United States
        • Westmoreland Regional Hospital
      • Hershey, Pennsylvania, United States
        • Hershey Medical Center
      • Philadelphia, Pennsylvania, United States
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania Medical Center
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center Stroke Institute
      • Upland, Pennsylvania, United States
        • Crozer Chester Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States
        • Miriam Hospital
    • South Carolina
      • Charleston, South Carolina, United States
        • Roper Hospital
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Chattanooga Neurology Associates (Erlanger Hospital)
      • Chattanooga, Tennessee, United States
        • Chattanooga Neurology Associates (Memorial Hospital)
      • Nashville, Tennessee, United States
        • St. Thomas Hospital
      • Nashville, Tennessee, United States
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States
        • University of Texas (Houston Medical Center)
    • Vermont
      • Bennington, Vermont, United States
        • Neurological Research Center, Inc
    • Virginia
      • Richmond, Virginia, United States
        • Neurology Associates, Inc. (St. Mary's Hospital)
      • Virginia Beach, Virginia, United States
        • Virginia Beach General Hospital
    • Washington
      • Edmonds, Washington, United States
        • Stevens Memorial Hospital
      • Olympia, Washington, United States
        • Providence St. Peter Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • St. Luke's Medical Center
      • Neenah, Wisconsin, United States
        • Theda Clark Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with acute ischemic stroke who are treated with alteplase within 3 hours of stroke onset (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night).
  • Patients who are able to provide written informed consent or have consent provided by a legally authorized representative.
  • Patients who are at least 18 years of age.
  • Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious.
  • Other criteria as specified in the study protocol

Exclusion Criteria:

  • Patients who are not eligible to receive treatment with alteplase (t-PA) due to brain hemorrhage, risk for hemorrhage, or other criteria.
  • Patients who have stroke of the brainstem or cerebellum.
  • Patients who have renal (kidney) disease or insufficiency.
  • Patients who have active epilepsy or convulsions during the current stroke episode.
  • Patients who are IV drug users or are inebriated.
  • Patients who have a history of drug-related anaphylaxis.
  • Patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment.
  • Patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment.
  • Patients who have a known vitamin hypersensitivity.
  • Other exclusion criteria as specified by the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma US, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion

January 1, 2003

Study Registration Dates

First Submitted

August 16, 2002

First Submitted That Met QC Criteria

August 19, 2002

First Posted (Estimate)

August 20, 2002

Study Record Updates

Last Update Posted (Estimate)

April 3, 2006

Last Update Submitted That Met QC Criteria

March 31, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 872-CL-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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