[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566864":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":49,"responsibleParty":77,"collaborators":30,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":30,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":52,"whyStopped":30,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Shin Poong Pharmaceutical Co. Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SP-8203","EXPERIMENTAL","SP-8203 80 mg (40 mg\u002Fdose twice a day for three days)",[13],"Drug: SP-8203",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo group: twice a day for three days",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","SP-8203 80 mg will be intravenously administered as 40 mg\u002Fdose twice daily (intervals of 12 hours)",[9],[26],"Otaplimastat (SP-8203)",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo will be intravenously administered twice daily (intervals of 12 hours)",[15],null,[32,36],{"name":33,"affiliation":34,"role":35},"Jong Sung Kim, MD, Phd","GangNeung Asan Medical Center","STUDY_CHAIR",{"name":37,"affiliation":38,"role":39},"Beom Jun Kim, MD, Phd","Seoul Asan Medical Center","PRINCIPAL_INVESTIGATOR",[41,45],{"name":33,"role":42,"phone":43,"phoneExt":30,"email":44},"CONTACT","+82-33-610-3114","jongskim@amc.seoul.kr",{"name":46,"role":42,"phone":47,"phoneExt":30,"email":48},"Byung Su Kim, MS","+82-70-5168-6503","135kbs@shinpoong.co.kr",[50,66],{"facility":51,"status":52,"city":53,"state":30,"zip":54,"country":55,"countryCode":30,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Dong-A University Hospital","RECRUITING","Busan","49201","South Korea",{"type":57,"coordinates":58},"Point",[59,60],129.03004,35.10168,{"lat":60,"lon":59},[63],{"name":64,"role":42,"phone":65,"phoneExt":30,"email":48},"Neurology","+82-31348-9354",{"facility":67,"status":52,"city":68,"state":30,"zip":69,"country":55,"countryCode":30,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Ulsan University Hospital","Ulsan","44033",{"type":57,"coordinates":71},[72,73],129.31667,35.53722,{"lat":73,"lon":72},[76],{"name":64,"role":42,"phone":65,"phoneExt":30,"email":48},{"type":78,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100566864","phase-3-efficacy-and-safety-of-sp-8203-otaplimastat-in-patients-with-acute-ischemic-stroke-receiving-thrombolytic-standard-of-care-100566864",false,"NCT06660719","Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care","A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase III Clinical Study to Evaluate Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Requiring Thrombolytic Therapy as Standard of Care","SP-8203-3001","Inclusion Criteria:\n\n* Patients with neurologic deficit of ≥ 8 points by National Institute of Health Stroke Scale (NIHSS) score\n* Patients with pre-stroke modified Rankin Scale (mRS) must be 0 or 1, which means they were able to carry out all usual duties and activities\n* Adults aged ≥19 years and ≤85 years\n* Patients who can receive thrombolytic standard of care within 4.5 hours after the onset of early symptoms of acute ischemic stroke\n* Patients available for brain Magnetic Resonance Imaging (MRI) scanning\n* Patients who consent to participate in this study\n\nExclusion Criteria:\n\n* Patients with systemic allergic diseases or hypersensitivity to specific drugs.\n* Patients who were diagnosed with myocardial infarction (MI) within the last 6 months.\n* Patients who had arrhythmia causing clinical symptoms such as dyspnea or palpitation within the last 6 months.\n* Patients showing the following abnormal ECG findings in stable condition at Emergency Room:\n\n  * The range of pulse rate - under 55\u002Fmin or exceed 120\u002Fmin\n  * 2nd or 3rd degree Atrioventricular (AV) block indicated in ECG\n  * Congenital or acquired QT syndrome indicated in ECG\n  * Pre-excitation syndrome indicated in ECG\n* Patients with severe heart failure of New York Heart Association (NYHA) Class III or Class IV.\n* Patients with fever (≥ 38℃) or infection signs which require antibiotic therapy at screening.\n* Patients with pulmonary diseases (asthma, Chronic Obstruction Pulmonary disease, and active tuberculosis etc.) who have being recently been treated more than 1 month at screening.\n* Patients with decreased hemoglobin (Hb\\\u003C 10g\u002FdL), decreased platelet count (PLT\\\u003C 100,000\u002Fmm3) or hematocrit of \\\u003C25% in complete blood count.\n* Patients who have undergone hemodialysis and\u002For treatments due to nephropathies, acute or chronic renal failure at screening.\n* Patients with a cancer in following conditions: diagnosed within 6 months before the screening time, or any treatment for cancer within the previous 6 months, or with recurrent\u002F metastatic cancer.\n* Pregnant and lactating women. However, Women of Childbearing Potential (WOCBP) can participate in the study only when non-pregnancy is confirmed. Women of Childbearing Potential (WOCBP) is defined as woman who is not definitely menopause and did not receive a surgical contraception.\n* Patients who do not consent to use double barrier contraception until 90 days from the first study intervention administration.\n* Patients who have participated in other clinical trials of other drugs within the past 3 months. However, if they participated in observational studies and did not take drugs, they can participate in this trial.\n* Patients who cannot participate in the study at the discretion of investigators\n* Patients who are unable to receive thrombolytic standard of care, rtPA","ALL","19 Years","85 Years",{"count":91,"type":92},852,"ESTIMATED","INTERVENTIONAL",[95],"PHASE3","This clinical study is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (otaplimastat) and thrombolytic standard of care in acute ischemic stroke patient.\n\nAs a standard of care, thrombolytic therapy (for instance, recombinant tissue plasminogen activator) will be administered. When reperfusion is not achieved in spite of thrombolytic therapy, endovascular therapy can be performed.",[98],"Ischemic Stroke",[100,101,102],"SP-8203 (Otaplimastat)","rtPA (recombinant tissue Plasminogen Activator)","Thrombolytic therapy","2025-03-04",{"date":105,"type":106},"2025-03-07","ACTUAL",{"date":108,"type":106},"2025-02-14",{"date":110,"type":92},"2027-03-30",{"name":5,"class":6},2]