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

Show 118 Study Locations

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 February 08, 2010