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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)

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ClinicalTrials.gov Identifier: NCT00044057
Recruitment Status : Completed
First Posted : August 20, 2002
Last Update Posted : April 3, 2006
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: YM872 (zonampanel), t-PA (alteplase) Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : December 2000
Estimated Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044057

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Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.

ClinicalTrials.gov Identifier: NCT00044057     History of Changes
Other Study ID Numbers: 872-CL-004
First Posted: August 20, 2002    Key Record Dates
Last Update Posted: April 3, 2006
Last Verified: March 2006

Keywords provided by Astellas Pharma Inc:

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