Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke
NCT ID: NCT02258880
Last Updated: 2015-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2014-09-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SUN13837
Drug: SUN13837 daily for 28 days.
SUN13837
Placebo
Placebo: Matching Placebo daily for 28 days
placebo
Interventions
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SUN13837
placebo
Eligibility Criteria
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Exclusion Criteria
1. Prior exposure to SUN13837
2. History of severe allergic reaction, whether explained or not, requiring a visit to the ER and/or medical intervention with epinephrine
3. Development of hemodynamic instability following the acute stroke
4. History of dementia, advanced Parkinson's disease, other significant movement disorders, or other clinically significant diseases which would jeopardize the safety of the subject or impact the validity of the study results
5. Presence of significant global or receptive aphasia
6. Presence of clinically significant abnormal laboratory values at the time of presentation in the ER
7. History of malabsorption or any gastrointestinal abnormality that could impair oral absorption
8. Finding of Grade 3 or 4 proliferative retinopathy on routine fundoscopic examination or history of proliferative retinopathy (Grade 3 or 4) in subjects with diabetes mellitus
9. Unable, as determined by the investigator, or unwilling to discontinue use of potent cytochrome (CYP) P450 3A4/5 inhibitors, potent CYP2D6 inhibitors, CYP3A inducers, or potent P glycoprotein (P gp) inhibitors
10. Current participation in another clinical study involving administration of an investigational product or history of such participation within 30 days of acute stroke onset
18 Years
85 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Ger Rikken, MD
Role: STUDY_DIRECTOR
Asubio Pharmaceuticals, Inc.
Locations
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Mobile, Alabama, United States
Encinita, California, United States
Oceanside, California, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Lexington, Kentucky, United States
Marrero, Louisiana, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Novi, Michigan, United States
Southfield, Michigan, United States
Kalispell, Montana, United States
Reno, Nevada, United States
Edison, New Jersey, United States
Summit, New Jersey, United States
Brooklyn, New York, United States
Chapel Hill, North Carolina, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Bryn Mawr, Pennsylvania, United States
Hershey, Pennsylvania, United States
Paoli, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Chattanooga, Tennessee, United States
Houston, Texas, United States
Mechanicsville, Virginia, United States
Midlothian, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Edmonton, Alberta, Canada
Victoria, British Columbia, Canada
Saint-Jérôme, Quebec, Canada
Haifa, , Israel
Haifa, , Israel
Holon, , Israel
Kfar Saba, , Israel
Naharyia, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Bloemfontein, Free State, South Africa
Alberton, Gauteng, South Africa
Krugersdorp, Gauteng, South Africa
Bellville, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Worcester, Western Cape, South Africa
Countries
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Other Identifiers
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ASBI 802
Identifier Type: -
Identifier Source: org_study_id
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