[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651323":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":30,"responsibleParty":34,"collaborators":30,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":30,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":62,"whyStopped":30,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":30},{"fullName":5,"class":6},"Cereno Scientific AB","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"CS1 320 mg","EXPERIMENTAL","2 capsules of CS1 160 mg and 2 capsules of placebo",[13,14],"Drug: CS1","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"CS1 640 mg","4 capsules of CS1 160 mg",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","4 capsules of placebo",[14],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","CS1","160 mg delayed release capsules taken orally once daily in the evening",[9,16],null,{"type":26,"name":20,"description":32,"armGroupLabels":33,"otherNames":30},"Matching placebo capsules taken orally once daily in the evening",[9,20],{"type":35,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","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":48,"type":49},126,"ESTIMATED","INTERVENTIONAL",[52],"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.",[55],"Pulmonary Arterial Hypertension",[27,55,57,58,59,60,61],"PAH","Sodium Valproate","Valproic Acid","Pulmonary Vascular Resistance","6-Minute Walk Distance","NOT_YET_RECRUITING","2026-08-06",{"date":65,"type":66},"2026-08-12","ACTUAL",{"date":68,"type":49},"2026-09-15",{"date":70,"type":49},"2029-04-30",{"name":5,"class":6}]