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Repinotan in Patients With Acute Ischemic Stroke
This study has been completed.
First Received: September 6, 2002   Last Updated: June 9, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Bayer:

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
Criteria

Inclusion Criteria:

  • Acute ischemic stroke of hemispheric localization (exclude brainstem and cerebellum), of suspected thromboembolic origin.
  • Males or females aged 18 years or over.
  • National Institute of Health Stroke Scale (NIH-SS) total score 8 to 23 with a motor deficit >/= 2 (for either one arm or leg) and level of consciousness < 2 and at least one of the following: Visual field deficit, neglect, or aphasia. If a patient receives t-PA, NIH-SS must be performed prior to receiving the study drug but after infusion of t-PA is initiated.
  • Signed informed consent from patient or legally authorized representative

Exclusion Criteria:

  • CT scan evidence of:
  • Clearly defined areas of hypodensity indicating infarction of >1/3 of the MCA territory or evidence of significant mass effect with shift of midline or major areas of sulcal effacement associated with loss of cortical definition (grey-white distinction). Minor early CT changes are common in MCA strokes and patients with early or subtle changes are eligible.
  • A primary intra-cerebral haemorrhage or any finding not consistent with an acute ischemic stroke as the cause of presenting symptoms.
  • Clinical evidence of acute stroke due to lacunar infarct (pure motor hemiplegia; pure sensory deficit, ataxia/clumsy hand syndromes)
  • Neurological (other than the presenting stroke) or psychiatric conditions that may affect the patient's functional status and/or that may interfere with the patient's assessment
  • Clinically relevant pre-existing neurological deficit (Historical Rankin score >/= 2 regardless of cause)
  • Generalized seizures having developed since the onset of stroke symptoms
  • Systolic blood pressure > 210 or < 110 mmHg (confirmed by up to three readings prior to randomization)
  • Diastolic blood pressure > 110 or < 60 mmHg (confirmed by up to three readings prior to randomization)
  • Myocardial infarction within 3 months, unstable angina within 3-5 days prior to starting infusion, unstable supra-ventricular and/or ventricular arrhythmia, severe conduction defect (AV block grades 2 and 3), complete left or right Bundle Branch Block, bradycardia (heart rate [HR] less than 50 bpm), uncompensated heart failure
  • History of myocarditis, cardiomyopathy or aortic stenosis
  • Patients known to have prolonged QTc intervals (inherited and sporadic syndromes of QTc prolongation or QTc interval > 450 msec males and 470 msec females on baseline ECG) or using Class IA or Class III antiarrhythmic drugs (e.g., quinidine, procainamide, amiodarone, sotalol)
  • Any patients that require initiation of new digoxin therapy are excluded. Patients already on digoxin therapy (for at least 1 month stable dose) at time of enrollment will be allowed in the study.
  • Electrolyte imbalance at baseline. Should the results not be available before starting the study drug infusion, the patients will be allowed in the study providing that the corrective therapy of any abnormal electrolyte results is implemented immediately upon availability of the laboratory report.
  • Any conditions predisposing to electrolyte imbalances (e.g., chronic vomiting, anorexia nervosa, bulimia nervosa) will also be excluded at baseline.
  • Participation in a research protocol for investigation of a pharmaceutical agent or innovative invasive procedure (including intra-arterial t-PA) within the past 30 days
  • Previously in the BRAIN-Study or treated with repinotan
  • Life expectancy of less than 6 months due to comorbid conditions
  • Any other known clinically significant medical disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal, endocrine, major uncompensated metabolic disturbances, respiratory, immunological, hematological or bleeding disorder, cancer, AIDS)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044915

  Hide Study Locations
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
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

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

Keywords provided by Bayer:
Acute Ischemic Stroke Without Hemorrhage

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009