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

NCT ID: NCT00044057

Last Updated: 2006-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2003-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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YM872 (zonampanel), t-PA (alteplase)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Locations

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University of South Alabama Stroke Center

Mobile, Alabama, United States

Site Status

Good Samaritan Hospital

Phoenix, Arizona, United States

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University of Arizona

Tucson, Arizona, United States

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East Bay Region Associates in Neurology

Berkeley, California, United States

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Providence St. Joseph's Medical Center

Burbank, California, United States

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Mercy San Juan Hospital

Carmichael, California, United States

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University of California Davis Medical Center

Davis, California, United States

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Scripps Memorial Hospital

Encinitas, California, United States

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Grossmont Hospital

La Mesa, California, United States

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UCLA Medical Center

Los Angeles, California, United States

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Tri-City Medical Center

Oceanside, California, United States

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Stanford University Medical Center

Palo Alto, California, United States

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Mercy General Hospital

Sacramento, California, United States

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Scripps Mercy Hospital

San Diego, California, United States

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University of California at San Diego

San Diego, California, United States

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Good Samaritan Hospital

San Jose, California, United States

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UCLA Medical Center - Santa Monica

Santa Monica, California, United States

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John Muir Medical Center

Walnut Creek, California, United States

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Mt Diablo Medical Center

Walnut Creek, California, United States

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Colorado Neurological Institute

Englewood, Colorado, United States

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Bridgeport Hospital

Bridgeport, Connecticut, United States

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Columbia JFK Hospital

Atlantis, Florida, United States

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Bethesda Memorial Hospital

Boynton Beach, Florida, United States

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Lakeland Regional Medical Center

Lakeland, Florida, United States

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Holmes Regional Medical Center

Melbourne, Florida, United States

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Bay Medical Center

Panama City, Florida, United States

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St Joseph's Hospital

Tampa, Florida, United States

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Tampa General Hospital

Tampa, Florida, United States

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St Francis Hospital

Columbus, Georgia, United States

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DNA Research (Dekalb Medical Center)

Decatur, Georgia, United States

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Candler Hospital

Savannah, Georgia, United States

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St Joseph Hospital

Savannah, Georgia, United States

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Queen's Medical Center

Honolulu, Hawaii, United States

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OSF St. Francis Medical Center

Peoria, Illinois, United States

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Parkview Hospital

Fort Wayne, Indiana, United States

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Methodist Hospital

Indianapolis, Indiana, United States

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Louisville Neuroscience Research Center

Louisville, Kentucky, United States

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Culicchia Neurology Clinic, LLP

Marrero, Louisiana, United States

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University of Maryland Medical System

Baltimore, Maryland, United States

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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New England Medical Center

Boston, Massachusetts, United States

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St John's Hospital

Detroit, Michigan, United States

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Michigan State University

East Lansing, Michigan, United States

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William Beaumont Hospital

Royal Oak, Michigan, United States

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Northern Michigan Neurology

Traverse City, Michigan, United States

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Bi-County Hospital

Warren, Michigan, United States

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Research Medical Center

Kansas City, Missouri, United States

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Advanced Neurology Specialists (Benefis Healthcare Hospital)

Great Falls, Montana, United States

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Washoe Comprehensive Stroke Center

Reno, Nevada, United States

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JFK Medical Center

Edison, New Jersey, United States

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Muhlenberg Regional Medical Center

Plainfield, New Jersey, United States

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Neurology Group of Bergen County (Valley Hospital)

Ridgewood, New Jersey, United States

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University of New Mexico Hospital

Albuquerque, New Mexico, United States

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VA Medical Center

Albuquerque, New Mexico, United States

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Albany Medical Center

Albany, New York, United States

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Buffalo General Hospital

Buffalo, New York, United States

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North Shore University Hospital

Manhasset, New York, United States

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Long Island Jewish Medical Center

New Hyde Park, New York, United States

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Columbia Presbyterian Medical Center

New York, New York, United States

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Roosevelt Hospital

New York, New York, United States

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St. Luke's Hospital

New York, New York, United States

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Rochester General Hospital

Rochester, New York, United States

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Ellis Hospital

Schenectady, New York, United States

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Stony Brook Hospital

Stony Brook, New York, United States

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Forsyth Medical Center

Winston-Salem, North Carolina, United States

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Rowan Regional Medical Center

Winston-Salem, North Carolina, United States

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Akron General Medical Center

Akron, Ohio, United States

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Metrohealth Medical Center

Cleveland, Ohio, United States

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Riverside Methodist Hospital

Columbus, Ohio, United States

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Medical College of Ohio

Toledo, Ohio, United States

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St. Elizabeth Health Center

Youngstown, Ohio, United States

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Lehigh Valley Hospital

Allentown, Pennsylvania, United States

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Geisinger Medical Center

Danville, Pennsylvania, United States

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Westmoreland Regional Hospital

Greensburg, Pennsylvania, United States

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Hershey Medical Center

Hershey, Pennsylvania, United States

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Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

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University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

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University of Pittsburgh Medical Center Stroke Institute

Pittsburgh, Pennsylvania, United States

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Crozer Chester Medical Center

Upland, Pennsylvania, United States

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Miriam Hospital

Providence, Rhode Island, United States

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Roper Hospital

Charleston, South Carolina, United States

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Chattanooga Neurology Associates (Erlanger Hospital)

Chattanooga, Tennessee, United States

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Chattanooga Neurology Associates (Memorial Hospital)

Chattanooga, Tennessee, United States

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St. Thomas Hospital

Nashville, Tennessee, United States

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

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University of Texas (Houston Medical Center)

Houston, Texas, United States

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Neurological Research Center, Inc

Bennington, Vermont, United States

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Neurology Associates, Inc. (St. Mary's Hospital)

Richmond, Virginia, United States

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Virginia Beach General Hospital

Virginia Beach, Virginia, United States

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Stevens Memorial Hospital

Edmonds, Washington, United States

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Providence St. Peter Hospital

Olympia, Washington, United States

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St. Luke's Medical Center

Milwaukee, Wisconsin, United States

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Theda Clark Medical Center

Neenah, Wisconsin, United States

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Universitätsklinik allgemeines Krankenhaus der Stadt Wien

Vienna, , Austria

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Dienst Neurologie UZ Gasthuisberg

Leuven, , Belgium

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Foothills Medical Centre

Calgary, Alberta, Canada

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University of Alberta Hospital

Edmonton, Alberta, Canada

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Penticton Regional Hospital

Penticton, British Columbia, Canada

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Vancouver General Hospital

Vancouver, British Columbia, Canada

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Royal Jubilee Hospital

Victoria, British Columbia, Canada

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Victoria General Hospital

Victoria, British Columbia, Canada

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Charles LeMoyne Hospital

Greenfield Park, Quebec, Canada

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Notre-Dame Hospital

Montreal, Quebec, Canada

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Pavillion St Joseph

Trois Rivers, Quebec, Canada

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Royal University Hospital

Saskatoon, Saskatchewan, Canada

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Universitätsklinikum Aachen, Neurologische Klinik

Aachen, , Germany

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Universität zu Köln klinik und poliklinik fur neurology

Cologne, , Germany

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University Essen

Essen, , Germany

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Neurologische Universitätsklinik

Freiburg im Breisgau, , Germany

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Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie

Hamburg-Eppendorf, , Germany

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Neurology Klinik Klinikum Hanover

Hanover, , Germany

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Friedrich-Schiller-University

Jena, , Germany

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Universitätsklinikum Leipzig

Leipzig, , Germany

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Universitätsklinik Mainz

Mainz, , Germany

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Neurologische Klinik Klinikum Rechts der Isar der TU Munchen

München, , Germany

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Neurologische Klinik Knappschafts - krankenhause

Recklinghausen, , Germany

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Neurologisch Psychiayrische Klinik

Weisbaden, , Germany

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Countries

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United States Austria Belgium Canada Germany

Other Identifiers

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872-CL-004

Identifier Type: -

Identifier Source: org_study_id