A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00044070 |
Recruitment Status :
Completed
First Posted : August 20, 2002
Last Update Posted : April 3, 2006
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Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
Tracking Information | |||
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First Submitted Date ICMJE | August 16, 2002 | ||
First Posted Date ICMJE | August 20, 2002 | ||
Last Update Posted Date | April 3, 2006 | ||
Study Start Date ICMJE | December 2000 | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients | ||
Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Effects of YM872 on Lesion Volume as Measured by Diffusion, Perfusion, and FLAIR Magnetic Resonance Imaging in Patients With Acute Ischemic Stroke | ||
Brief Summary | This study will investigate the effects of a potential neuroprotectant compound, YM872, in the treatment of acute ischemic stroke. The study will determine if a 24-hour infusion of YM872, given within 6 hours of stroke onset, reduces the ischemic lesion volume as measured by MRI at 28 days after the infusion is given. The clinical effects of YM872 will also be determined by neurological function and disability scores at follow up visits through Day 90 of the study. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Cerebrovascular Accident | ||
Intervention ICMJE | Drug: YM872 (zonampanel) | ||
Study Arms ICMJE | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Study Completion Date ICMJE | January 2003 | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Austria, Belgium, Canada, Germany, South Africa, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00044070 | ||
Other Study ID Numbers ICMJE | 872-CL-003 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Astellas Pharma Inc | ||
Collaborators ICMJE | Astellas Pharma US, Inc. | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Astellas Pharma Inc | ||
Verification Date | March 2006 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |