[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605825":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":127,"collaborators":25,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":25,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":25,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":152,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Tatchempharmpreparaty, JSC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dimephosphon®","EXPERIMENTAL","Days 1-3: Dimephosphon® 2 g (2 vials) administered as intravenous infusion diluted in 200 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).\n\nDays 4-14: Dimephosphon® 2 g (2 vials) administered as intravenous bolus diluted in 20 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).",[13],"Drug: Dimephosphon®",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Days 1-3: Placebo 2 g (2 vials) administered as intravenous infusion diluted in 200 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).\n\nDays 4-14: Placebo 2 g (2 vials) administered as intravenous bolus diluted in 20 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","1 g\u002Fml, concentrate for solution for intravenous infusion",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo IV solution",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Alfiya Fakhrieva","CONTACT","+78435269764","iksanova@tatpharm.ru",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Alyona Tirskaya","+7812309847","atirskaya@x7research.ru",[40,59,74,88,99,113],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"State Budgetary Healthcare Institution of the Leningrad Region \"Vsevolozhsk Interdistrict Clinical Hospital","RECRUITING","Vsevolozhsk","Leningradskaya Oblast'","188643","Russia","RU",{"type":49,"coordinates":50},"Point",[51,52],30.67314,60.01512,{"lat":52,"lon":51},[55],{"name":56,"role":32,"phone":57,"phoneExt":25,"email":58},"Liya Lukinyh","+78137028786","Liya.lukinyh@mail.ru",{"facility":60,"status":61,"city":62,"state":25,"zip":63,"country":46,"countryCode":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"State Budgetary Healthcare Institution \"Research Institute - Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky\" of the Ministry of Health of the Krasnodar region","NOT_YET_RECRUITING","Krasnodar","350086",{"type":49,"coordinates":65},[66,67],38.98178,45.04534,{"lat":67,"lon":66},[70],{"name":71,"role":32,"phone":72,"phoneExt":25,"email":73},"Ludmila Timchenko","88622527390","tlv2908@yandex.ru",{"facility":75,"status":42,"city":76,"state":25,"zip":77,"country":46,"countryCode":47,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Federal State Autonomous Educational Institution of Higher Education \"Peoples' Friendship University of Russia named after Patrice Lumumba\"","Moscow","117198",{"type":49,"coordinates":79},[80,81],37.61781,55.75204,{"lat":81,"lon":80},[84],{"name":85,"role":32,"phone":86,"phoneExt":25,"email":87},"Oleg Artyukov","84991359117","denars1@yandex.ru",{"facility":89,"status":42,"city":76,"state":25,"zip":90,"country":46,"countryCode":47,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"The FSBI \"Federal Center of Brain Research and Neurotechnologies\" of the Federal Medical and Biological Agency","117513",{"type":49,"coordinates":92},[80,81],{"lat":81,"lon":80},[95],{"name":96,"role":32,"phone":97,"phoneExt":25,"email":98},"Nikolay Shamalov","+74952803550","shamalovn@gmail.com",{"facility":100,"status":42,"city":101,"state":25,"zip":102,"country":46,"countryCode":47,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Saint Petersburg State Budgetary Healthcare Institution \"City Hospital No. 40 of the Kurortny District\"","Saint Petersburg","197706",{"type":49,"coordinates":104},[105,106],30.31413,59.93863,{"lat":106,"lon":105},[109],{"name":110,"role":32,"phone":111,"phoneExt":25,"email":112},"Alina Agafina","+78124373522","a.agafina@mail.ru",{"facility":114,"status":42,"city":115,"state":25,"zip":116,"country":46,"countryCode":47,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"State Budgetary Healthcare Institution \"City Hospital No. 4 of Sochi\" of the Ministry of Healthcare of the Krasnodar Region","Sochi","354057",{"type":49,"coordinates":118},[119,120],39.72477,43.59699,{"lat":120,"lon":119},[123],{"name":124,"role":32,"phone":125,"phoneExt":25,"email":126},"Vadim Bucev","89183430176","da-signa84@rambler.ru",{"type":128,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100605825","phase-3-the-study-of-efficacy-and-safety-of-dimephosphon-in-acute-ischemic-stroke-100605825",false,"NCT07167550","The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke","Multicenter, Randomized, Double-blind, Placebo-controlled Comparative Study of the Efficacy and Safety of the Drug Dimephosphon®, Concentrate for Solution for Intravenous Administration, 1 g, in Acute Ischemic Stroke Patients","Inclusion Criteria:\n\n1. Written informed consent was obtained from the patient or their legally authorized representative prior to study participation.\n2. Age 35-80.\n3. Patients must exhibit neurological manifestations consistent with acute ischemic stroke, with a documented onset-to-intervention interval ranging from 24 to 72 hours at the time of scheduled initial administration of the investigational drug.\n4. Verified by CT\u002FMRI current hemispheric ischemic stroke.\n5. NIHSS score ≥5 and ≤15 at screening.\n6. Ability to comply with all protocol-specified procedures, prohibitions, and restrictions.\n7. Willingness and ability to adhere to highly effective contraceptive methods as outlined in the study protocol.\n\nExclusion Criteria:\n\n1. Hemorrhagic stroke or hemorrhagic transformation of ischemic focus, traumatic brain injuries\n2. Vertebrobasilar stroke and\u002For development of acute insufficiency syndromes in the arteries of the vertebrobasilar system\n3. A patient with ischemic stroke who is a candidate for reperfusion therapy or who has undergone reperfusion therapy before participation in this study.\n4. The presence of anatomical abnormalities of the cerebral vessels (arteriovenous malformations, cavernous malformations, aneurysms, atresia of at least one of the extracranial arteries) according to the anamnesis or CT\u002FMRI data.\n5. Progression of neurological symptoms of stroke, defined as an increase in the NIHSS score by 4 points at the second assessment (immediately before randomization) from the value obtained at the first assessment (immediately after signing the informed consent form).\n6. Surgery on the carotid arteries less than 1 year before screening.\n7. History of stroke less than 1 year before screening.\n8. Myocardial infarction less than 6 months before screening.\n9. Chronic renal failure stage 2-3 (creatinine clearance less than 40 ml\u002Fmin).\n10. Pregnancy or lactation.\n11. Participation in another trial within 28 days prior to enrollment.\n12. Use of prohibited medications.","ALL","35 Years","80 Years",{"count":140,"type":141},184,"ESTIMATED","INTERVENTIONAL",[144],"PHASE3","A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke",[147,148,149,150,151],"Stroke","Acute Stroke","Ischemic Stroke","Cerebrovascular Disorders","Physiological Effects of Drugs",[153,154,155,156,157,158,148,149,159],"Neuroprotective Agents","Protective Agents","Neuroprotection","Anti-acidemic agents","Dimephosphon","Dimethyloxobutylphosphonyldimethylate","Antioxidants","2025-09-10",{"date":162,"type":163},"2025-09-11","ACTUAL",{"date":165,"type":141},"2025-09-06",{"date":167,"type":141},"2026-04-30",{"name":5,"class":6},6]