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Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke Clinical research trials and Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke. Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke  Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke
Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke
For Condition: Acute ischemic stroke
Status: Recruiting
Sponsor(s): Bayer Corporation ,
Synopsis: Evaluation of 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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) or any medication listed in section 12.15 NOTE: Three baseline ECGs will be performed within 20 min (every 10 minutes). For calculation of the baseline QTc, the mean of the multiple baseline measurements will be used. - 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)
Total Enrollment: 770
Location and Contact Information:
North County Neurology Associates *Not yet recruiting*
Oceanside, California, 92056
United States
Not yet recruiting
Lehigh Valley Hospital, Neurosciences and Pain Research *Not yet recruiting*
Allentown, Pennsylvania, 18103
United States
Not yet recruiting
Sarasota Memorial Hospital, Clinical Research Center *Not yet recruiting*
Sarasota, Florida, 34239
United States
Not yet recruiting
Columbia University Neurological Institute *Not yet recruiting*
New York City, New York, 10032
United States
Not yet recruiting
Neurological Consultants *Not yet recruiting*
Hollywood, Florida, 33021
United States
Not yet recruiting
Johns Hopkins University School of Medicine *Not yet recruiting*
Baltimore, Maryland, 21287
United States
Not yet recruiting
LSU Health Sciences Center, Department of Neurology *Not yet recruiting*
Shreveport, Louisiana, 71130
United States
Not yet recruiting
Advanced Neurology Specialists *Recruiting*
Great Falls, Montana, 59405
United States
Recruiting
University Hospitals of Cleveland, Department of Neurosurgery *Not yet recruiting*
Cleveland, Ohio, 44106
United States
Not yet recruiting
UPMC Health System *Not yet recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Not yet recruiting
Oregon Health Sciences University *Not yet recruiting*
Portland, Oregon, 97201
United States
Not yet recruiting
Mercy General Hospital *Not yet recruiting*
Sacramento, California, 95819
United States
Not yet recruiting
UCSD Medical Center *Not yet recruiting*
San Diego, California, 92103
United States
Not yet recruiting
Long Island Jewish Medical Center *Not yet recruiting*
New Hyde Park, New York, 11040
United States
Not yet recruiting
Beth Israel Deaconess Medical Center, Neurology/Stroke Service *Not yet recruiting*
Boston, Massachusetts, 02215
United States
Not yet recruiting
Forsyth Medical Center *Recruiting*
Winston Salem, North Carolina, 27103
United States
Recruiting
Mercy Run Neurology Clinic *Not yet recruiting*
Des Moines, Iowa, 50314
United States
Not yet recruiting
Florida Neurovascular Institute *Not yet recruiting*
Tampa, Florida, 33606
United States
Not yet recruiting
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting
Neurology Group - Bergen County *Not yet recruiting*
Ridgewood, New Jersey, 07450
United States
Not yet recruiting
Huntsville Hospital, Neurology Unit *Not yet recruiting*
Huntsville, Alabama, 35801
United States
Not yet recruiting
Mercy Hospital of Pittsburgh *Not yet recruiting*
Pittsburgh, Pennsylvania, 15219
United States
Not yet recruiting
Barnes-Jewish Hospital *Not yet recruiting*
St. Louis, Missouri, 63110
United States
Not yet recruiting
Monroe Regional Medical Center *Not yet recruiting*
Ocala, Florida, 34471
United States
Not yet recruiting
Additional Information:
Study ID Numbers: Protocol No. 100282;
Study Start Date: August 2002
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044915
Other Acute Ischemic Stroke Studies:
1. Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke
2. A study to evaluate the effects of YM872 on brain function and disability when administered in combination with alteplase (tissue plasminogen activator)
Related Studies:
Other Acute ischemic stroke Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Safety, Efficacy, and Tolerability of Repinotan in Patients with Acute Ischemic Stroke
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