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.
Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00044057
First received: August 16, 2002
Last updated: March 31, 2006
Last verified: March 2006
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
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
Show 118 Study LocationsSponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00044057 History of Changes |
| Other Study ID Numbers: | 872-CL-004 |
| Study First Received: | August 16, 2002 |
| Last Updated: | March 31, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
ARTIST |
Additional relevant MeSH terms:
|
Ischemia Stroke Cerebral Infarction Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction |
Brain Ischemia Plasminogen Tissue Plasminogen Activator Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013