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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00153036 |
Purpose
To collect additional confirmatory data on alteplase(rt-PA) in the European setting and to demonstrate that the treatment of patients between 3 and 4.30 hours of onset of symptoms of acute ischemic stroke with rt-PA compared to placebo-treated patients will result in an improved clinical outcome without increase of fatality rate.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebrovascular Accident |
Drug: rt-PA 0.9 mg/kg verum or placebo Intravenous |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Placebo Controlled Trial of Alteplase in Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.30 Hours After Stroke Onset. |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 142 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 135.312 |
| Study First Received: | September 9, 2005 |
| Last Updated: | September 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00153036 History of Changes |
| Health Authority: | Austria: Bundesministerium fuer Gesundheit und Frauen; Belgium: Federal Agency for Medicines and Health Products; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency; France: AFSSAPS; Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte BfArm; Great Britain: MHRA; Greece: HELLENIC REPUBLIC MINISTRY OF HEALTH AND WELFARE; Hungary: National Institute of Pharmacy, H-1051 Budapest; Italy: Comitato Etico Policlinico Umberto I - Università degli Studi di Roma La Sapienza; Netherlands: Academical Medical Centre; Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych, PL-00725 Warsaw; Portugal: INFARMED - National Authority of Medicines and Health Products, IP; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Spain: Agencia Española de Medicamentos y Productos Santarios; Sweden: Medical Product Agency; Switzerland: Swissmedic |
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Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Brain Ischemia Cardiovascular Diseases Brain Infarction Brain Diseases Cerebrovascular Disorders |