[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shin Poong Pharmaceutical Co. Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"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":21,"type":22},852,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Ischemic Stroke",[30,31,32],"SP-8203 (Otaplimastat)","rtPA (recombinant tissue Plasminogen Activator)","Thrombolytic therapy","RECRUITING","2025-03-04",{"date":36,"type":37},"2025-03-07","ACTUAL",{"date":39,"type":37},"2025-02-14",{"date":41,"type":22},"2027-03-30",{"name":43,"class":44},"Shin Poong Pharmaceutical Co. Ltd.","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100579636","phase-2-efficacy-and-safety-of-spc1001-in-patients-with-essential-hypertension-100579636","NCT06826872","Efficacy and Safety of SPC1001 in Patients With Essential Hypertension","A Multicenter, Randomized, Double-Blind, Parallel, Phase 2(2b) Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 in Patients With Essential Hypertension","Inclusion Criteria:\n\n* Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.\n\nExclusion Criteria:\n\n* Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.","75 Years",{"count":54,"type":22},252,[56],"PHASE2","\\- Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to dual-component therapies of each ingredient for 8 weeks. Additionally, it seeks to confirm the contribution of each component at low doses.\n\n\\- Inclusion Criteria: Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.\n\n\\- Exclusion Criteria: Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.\n\n\\- Methods: This study is a multicenter, randomized, double-blind, parallel-group, phase 2b clinical trial to evaluate the safety and efficacy of the investigational drug after 8 weeks of administration.\n\nScreening assessments will be conducted within 4 weeks prior to randomization, and patients who meet the inclusion and exclusion criteria at the screening visit will be enrolled in the study after providing informed consent. These participants will undergo a 2-week run-in period during which they will take a placebo and participate in a lifestyle modification program.",[59,60,61],"Hypertension, Essential","Cardiovascular Diseases","Cardiology",[63,64,65,66,67],"blood pressure","Low-dose combination therapy","candesartan","amlodipine","indapamide","2025-02-10",{"date":39,"type":37},{"date":71,"type":37},"2024-06-12",{"date":73,"type":22},"2025-12-30",{"name":43,"class":44},1,""]