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A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)
This study has been completed.
First Received: August 16, 2002   Last Updated: March 31, 2006   History of Changes
Sponsor: Astellas Pharma Inc
Collaborator: Astellas Pharma US, Inc.
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00044057
  Purpose

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.


Condition Intervention Phase
Acute Ischemic Stroke
 Drug: YM872 (zonampanel), t-PA (alteplase)
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Alteplase Tissue-type plasminogen activator YM 872
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Study Start Date: December 2000
Estimated Study Completion Date: January 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044057

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

No publications provided

Study ID Numbers: 872-CL-004
Study First Received: August 16, 2002
Last Updated: March 31, 2006
ClinicalTrials.gov Identifier: NCT00044057     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ARTIST

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Cardiovascular Agents
 Ischemia
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Fibrin Modulating Agents
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Plasminogen

ClinicalTrials.gov processed this record on November 30, 2009



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