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Sponsors and Collaborators: |
Mitsubishi Tanabe Pharma Corporation Kyowa Hakko Kogyo Co., Ltd. |
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Information provided by: | Mitsubishi Tanabe Pharma Corporation |
ClinicalTrials.gov Identifier: | NCT00412867 |
The purpose of this study is to confirm the efficacy and safety of intravenously administered alteplase in patients with acute ischemic stroke based on the rate of recanalization assessed by magnetic resonance angiography (MRA), the rate of patients with a modified Rankin Scale (mRS) score of 0-1, and the incidence of symptomatic intracranial hemorrhage (sICH), in comparison with the data reported in the current literature.
Condition | Intervention | Phase |
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Stroke |
Drug: Alteplase |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Post-Marketing Clinical Study of Alteplase for Acute Ischemic Stroke (Phase 4) |
Estimated Enrollment: | 50 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mitsubishi Tanabe Clinical Trials Information Desk | cti-inq-ml@ml.mt-pharma.co.jp | |
Contact: Kyowa Hakko Kirin Clinical Trials Information Desk | clinical.info@kyowa-kirin.co.jp |
Japan | |
National Hospital Organization Kyushu Medical Center | Recruiting |
Fukuoka-shi, Japan |
Study Chair: | Takenori Yamaguchi, M.D. | National Cardiovascular Center |
Responsible Party: | Mitsubishi Tanabe Pharma Corporation ( General Manager, Clinical Research Department I ) |
Study ID Numbers: | 527-0611 |
Study First Received: | December 17, 2006 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00412867 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Cerebral Infarction acute ischemic stroke Brain ischemia |
Cerebral Infarction Stroke Vascular Diseases Tissue Plasminogen Activator Central Nervous System Diseases Brain Ischemia |
Brain Infarction Ischemia Brain Diseases Infarction Plasminogen Cerebrovascular Disorders |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents Nervous System Diseases |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |