[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cereno Scientific AB\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100651323","phase-2-cs1-added-to-standard-of-care-therapy-for-pulmonary-arterial-hypertension-100651323",false,"NCT07761572","CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension","A Phase 2b, Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study, to Compare the Efficacy and Safety\u002FTolerability of CS1 Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)","EPIMODE","Inclusion Criteria:\n\n* Age 18 to 80 years\n* WHO Group 1 pulmonary arterial hypertension\n* WHO Functional Class II or III\n* REVEAL Lite 2 score ≥6\n* Receiving stable standard-of-care PAH therapy for at least 90 days prior to screening\n* Hemodynamic confirmation of PAH by right heart catheterization\n* 6-minute walk distance ≥150 m and \\\u003C550 m\n\nExclusion Criteria:\n\n* Pulmonary hypertension WHO Group 2, 3, 4, or 5\n* Significant left-sided heart disease\n* Recent major cardiovascular or cerebrovascular event\n* Prior heart or heart-lung transplantation or active lung transplant listing\n* Significant renal or hepatic dysfunction\n* Current use of prohibited medications that cannot be discontinued\n* Pregnant or breastfeeding","ALL","18 Years","80 Years",{"count":21,"type":22},126,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This Phase 2 study (EPIMODE) will evaluate the efficacy and safety of CS1 compared with placebo when added to standard-of-care therapy in participants with pulmonary arterial hypertension.\n\nParticipants completing Treatment Period 1 (Week 36) will be re-randomized to continue or switch study treatment for Treatment Period 2 through Week 52.",[28],"Pulmonary Arterial Hypertension",[30,28,31,32,33,34,35],"CS1","PAH","Sodium Valproate","Valproic Acid","Pulmonary Vascular Resistance","6-Minute Walk Distance","NOT_YET_RECRUITING","2026-08-06",{"date":39,"type":40},"2026-08-12","ACTUAL",{"date":42,"type":22},"2026-09-15",{"date":44,"type":22},"2029-04-30",{"name":46,"class":47},"Cereno Scientific AB","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":4,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":64,"locationsCount":65},"100540812","safety-and-efficacy-of-continued-cs1-treatment-of-patients-with-pulmonary-arterial-hypertension-100540812","NCT06321705","Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension","Expanded Access, Open-Label, Safety Extension Study for Patients That Have Completed Parent Study CS1-003 and Who Are Judged by the Investigator to Benefit From Continued CS1 Treatment","Inclusion Criteria:\n\n1. Patient has derived benefit from CS1 treatment in parent Study CS1-003 based on the Investigator's judgement and the benefit of continued CS1 treatment outweighs the risk or the patient could benefit from continued treatment with CS1.\n2. Patient must be willing and able to sign a written informed consent prior to any study-related procedures and able to understand and follow instructions; return to the study unit for specified study visits; and able to participate in the study for the entire period.\n3. Patient is classified as New York Heart Association\u002FWorld Health Organisation (NYHA\u002FWHO) functional Class I, II or III.\n4. Patient has CardioMEMS PA Sensor implanted and has completed treatment per parent protocol in Phase 2 Study CS1-003.\n5. Female patient of childbearing potential must be willing and able to practice effective contraception during the study and continuing contraception for 30 days after their last dose of study drug. A female patient of non-childbearing potential is defined as being surgically sterilized by bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. A female patient 45 to 60 years of age, who is post-menopausal for at least 1 year, and has a follicle-stimulating hormone level confirmation indicating post menopausal status will be considered of non-childbearing potential. A female patient \\>60 years of age is considered post menopausal and of non childbearing potential.\n\nExclusion Criteria:\n\n1. Patient has a concomitant medical disorder that is expected to limit the patient's life-expectancy to ≤1 year.\n2. Patient has thrombocytopenia: platelets \\\u003C100,000\u002Fmm3.\n3. Patient has a recent history of pancreatic disease.\n4. Patient is a pregnant or lactating female.\n5. Patient has active coronavirus disease 19 (COVID-19); however, those with previous COVID 19 are permitted.\n6. Patient is participating in another investigational study which, in the opinion of the Investigator, would interfere with the study compliance or outcome assessments.\n7. Patient is on regular treatment with other anti-epilepsy drugs or other prohibited medications (See Section 6.8.1) that cannot be discontinued at Roll-over or Restart Visit (V1).\n8. Patient is on regular anticoagulation or on antiplatelet therapy that cannot be discontinued. A low daily dose aspirin (\\\u003C125 mg) is allowed, ie, \"baby\" aspirin.\n9. Patient has significant liver dysfunction as measured by any one of the following at Roll-over or Restart Visit (V1) (including patients with acute or chronic hepatitis as well as patients with own or family history of serious hepatitis, especially drug related):\n\n   1. Alanine aminotransferase (ALT) \\>2.0 × upper limit of normal (ULN).\n   2. Aspartate aminotransferase (AST) \\>2.0 × ULN.\n   3. Serum bilirubin ≥1.6 mg\u002FdL or \\>2.0 × ULN.\n10. Patient with any major surgical procedure or trauma within 30 days prior to Roll-over or Restart Visit (V1) or planned surgical procedure during the study period.\n11. Patient has known hypersensitivity to study drug or any of the excipients of the drug formulation.\n12. Patient prematurely discontinued CS1 treatment in parent Study CS1-003 due to safety concerns of the Investigator.","EXPANDED_ACCESS","CS1-004 will be an extension of the CS1-003 Study. The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1.",[28],[28,59],"CardioMEMS","AVAILABLE","2024-03-14",{"date":63,"type":40},"2024-03-20",{"name":46,"class":47},1,""]