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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00044915 |
Purpose
The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke Acute Ischemic Stroke |
Drug: Repinotan HCl (BAYX3702) Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic / Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke |
| Enrollment: | 782 |
| Study Start Date: | December 2000 |
| Study Completion Date: | September 2004 |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Active Comparator |
Drug: Repinotan HCl (BAYX3702)
All patients receive 1.25 mg of repinotan
|
| Arm 2: Placebo Comparator |
Drug: Placebo
All patients receive 1.25 mg of placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| Oceanside, California, United States, 92056-4405 | |
| San Diego, California, United States, 92103-8765 | |
| San Jose, California, United States, 95124 | |
| Los Angeles, California, United States, 90024-1777 | |
| United States, Florida | |
| Ocala, Florida, United States, 34471 | |
| Tampa, Florida, United States, 33606 | |
| Boynton Beach, Florida, United States, 33435-6000 | |
| Ft. Lauderdale, Florida, United States, 33308 | |
| United States, Georgia | |
| Decatur, Georgia, United States, 30033 | |
| United States, Hawaii | |
| Honolulu, Hawaii, United States, 96813-2413 | |
| United States, Iowa | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Minnesota | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| United States, Montana | |
| Great Falls, Montana, United States, 59405 | |
| United States, New Jersey | |
| Ridgewood, New Jersey, United States, 07450 | |
| Edison, New Jersey, United States, 08818-3903 | |
| United States, New York | |
| New Hyde Park, New York, United States, 11040-1496 | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Chapel Hill, North Carolina, United States, 27599-7065 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44109-1998 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Upland, Pennsylvania, United States, 19013-3995 | |
| United States, South Carolina | |
| Beaufort, South Carolina, United States, 29902-5472 | |
| United States, Tennessee | |
| Chattanooga, Tennessee, United States, 37403-2112 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Bellevue, Washington, United States, 98004-4687 | |
| Australia, New South Wales | |
| Gosford, New South Wales, Australia, 2250 | |
| New Lambton Heights, New South Wales, Australia, 2305 | |
| Australia, Queensland | |
| Southport, Queensland, Australia, 4215 | |
| Australia, Tasmania | |
| Hobart, Tasmania, Australia, 7000 | |
| Australia, Victoria | |
| Melbourne, Victoria, Australia, 3052 | |
| Melbourne, Victoria, Australia, 3084 | |
| Melbourne, Victoria, Australia, 3181 | |
| Melbourne, Victoria, Australia, 3011 | |
| Austria | |
| Wien, Austria, 1021 | |
| Austria, Niederösterreich | |
| Klosterneuburg, Niederösterreich, Austria, 3400 | |
| Austria, Oberösterreich | |
| Linz, Oberösterreich, Austria, 4020 | |
| Belgium | |
| BORNEM, Belgium, 2880 | |
| BRUXELLES - BRUSSEL, Belgium, 1200 | |
| Canada, Alberta | |
| Lethbridge, Alberta, Canada, T1KOC9 | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, British Columbia | |
| North Vancouver, British Columbia, Canada, V7L 2L3 | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Victoria, British Columbia, Canada, V8Z 6R5 | |
| Penticton, British Columbia, Canada, V2A 3G6 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, New Brunswick | |
| St. John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| London, Ontario, Canada, N6A 5A5 | |
| Mississauga, Ontario, Canada, L5B 1B8 | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Canada, Quebec | |
| Quebec City, Quebec, Canada, G1J 1Z4 | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Chicoutimi, Quebec, Canada, G7H 5H6 | |
| Canada, Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Finland | |
| Helsinki, Finland, 00290 | |
| Mikkeli, Finland, FIN-50100 | |
| Lahti, Finland, 15850 | |
| Kuopio, Finland, 70120 | |
| France | |
| BORDEAUX, France, 33000 | |
| NICE, France, 06200 | |
| Germany | |
| Berlin, Germany, 10117 | |
| Berlin, Germany, 10249 | |
| Germany, Baden-Württemberg | |
| Tübingen, Baden-Württemberg, Germany, 72076 | |
| Heidelberg, Baden-Württemberg, Germany, 69120 | |
| Freiburg, Baden-Württemberg, Germany, 79106 | |
| Germany, Bayern | |
| München, Bayern, Germany, 81377 | |
| Erlangen, Bayern, Germany, 91054 | |
| Regensburg, Bayern, Germany, 93053 | |
| München, Bayern, Germany, 81545 | |
| Bad Neustadt, Bayern, Germany, 97616 | |
| Würzburg, Bayern, Germany, 97080 | |
| Nürnberg, Bayern, Germany, 90419 | |
| Aschaffenburg, Bayern, Germany, 63739 | |
| Germany, Hessen | |
| Frankfurt, Hessen, Germany, 60596 | |
| Germany, Mecklenburg-Vorpommern | |
| Greifswald, Mecklenburg-Vorpommern, Germany, 17489 | |
| Germany, Nordrhein-Westfalen | |
| Minden, Nordrhein-Westfalen, Germany, 32427 | |
| Essen, Nordrhein-Westfalen, Germany, 45147 | |
| Köln, Nordrhein-Westfalen, Germany, 50931 | |
| Münster, Nordrhein-Westfalen, Germany, 48149 | |
| Germany, Rheinland-Pfalz | |
| Kaiserslautern, Rheinland-Pfalz, Germany, 67655 | |
| Germany, Sachsen | |
| Leipzig, Sachsen, Germany, 04103 | |
| Germany, Sachsen-Anhalt | |
| Magdeburg, Sachsen-Anhalt, Germany, 39112 | |
| Hungary | |
| Miskolc, Hungary, 3526 | |
| Israel | |
| Tel Hashomer, Israel, 52621 | |
| Tel Aviv, Israel, 64239 | |
| Nahariya, Israel, 22100 | |
| Holon, Israel, 58100 | |
| Haifa, Israel, 31048 | |
| Haifa, Israel, 31096 | |
| Ashkelon, Israel, 78306 | |
| Israel, Isarel | |
| Petach Tikva, Isarel, Israel, 49372 | |
| Italy | |
| Pavia, Italy, 27100 | |
| L'Aquila, Italy, 67100 | |
| Vicenza, Italy, 36100 | |
| Verona, Italy, 37126 | |
| Reggio Emilia, Italy, 42100 | |
| Milano, Italy, 20153 | |
| Perugia, Italy, 06126 | |
| Roma, Italy, 00155 | |
| Como, Italy, 22100 | |
| Vibo Valentia, Italy, 89900 | |
| Netherlands | |
| GRONINGEN, Netherlands, 9713 GZ | |
| NIJMEGEN, Netherlands, 6525 GA | |
| Spain | |
| Valencia, Spain, 46010 | |
| Barcelona, Spain, 08035 | |
| Madrid, Spain, 28046 | |
| Barcelona, Spain, 08003 | |
| Zaragoza, Spain, 50009 | |
| Spain, A Coruña | |
| Santiago de Compostela, A Coruña, Spain, 15706 | |
| Sweden | |
| Stockholm, Sweden, 171 76 | |
| Umeå, Sweden, 901 85 | |
| United Kingdom, Leicestershire | |
| Leicester, Leicestershire, United Kingdom, LE1 5WW | |
| United Kingdom, Strathclyde | |
| Glasgow, Strathclyde, United Kingdom, G51 4TG | |
| United Kingdom, Tayside | |
| Dundee, Tayside, United Kingdom, DD2 1UB | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 100282 |
| Study First Received: | September 6, 2002 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00044915 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Ischemic Stroke Without Hemorrhage |
|
Pathologic Processes Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Brain Ischemia |
Central Nervous System Diseases Cardiovascular Diseases Brain Infarction Ischemia Brain Diseases Cerebrovascular Disorders |