[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639334":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":30,"responsibleParty":37,"collaborators":30,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":30,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":65,"whyStopped":30,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":30},{"fullName":5,"class":6},"VIVUS LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VI-0106","EXPERIMENTAL","Extended-release tacrolimus dosages of 1.25 mg or 0.625 mg oral capsules; once daily; Week 0-24, Week 28-52 during double-blind treatment period; Week 52-104 during open-label treatment period.",[13],"Drug: VI-0106",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo oral capsule; once daily; Week 0-52 during double-blind treatment period.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Tacrolimus Extended-Release Capsules",[9],[26],"Tacrolimus",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Inactive oral capsule",[15],null,[32],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"VIVUS Clinical","CONTACT","650-934-5200","clinical@vivus.com",{"type":38,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100639334","phase-3-a-phase-3-study-of-extended-release-tacrolimus-in-subjects-with-pulmonary-arterial-hypertension-and-functional-limitations-100639334",false,"NCT07612657","A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations","A Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of VI-0106 (Extended-release Tacrolimus) in Subjects With PAH and Functional Limitations Despite Optimized Treatment With Available PAH Medications","TRANSCEND","Inclusion Criteria:\n\n* WHO Group 1 PH: Pulmonary Arterial Hypertension;\n* WHO functional class II - IV despite optimized treatment with one or more modalities. Treatments for PAH must be stable for at least 3 months at the time of screening;\n* Right heart catheterization (RHC) at screening (or within 3 months prior to screening);\n* Screening 6MWD \\>75 meters to ≤450 meters.\n\nExclusion Criteria:\n\n* PAH due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis\n* Chronic thromboembolic or portopulmonary hypertension\n* Total Lung Capacity (TLC) \\\u003C60% predicted;\n* FEV1\u002FFVC \\\u003C70% predicted or FEV1 \\\u003C60% predicted;\n* Evidence of left-sided heart disease;\n* Inability to safely attempt completion of the 6MWD;\n* Life expectancy \\\u003C6 months;\n* eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI equation);\n* Moderate to severe hepatic dysfunction (Child-Pugh score \\>10);\n* Serum potassium \\>5.1 mEq\u002FL;\n* Use of experimental PAH treatments within the past 3 months;\n* Active infection requiring antibiotic, antifungal, or antiviral therapies;\n* Current systemic treatment with cyclosporine;\n* Known allergy or hypersensitivity to tacrolimus;\n* Significant psychiatric, addictive, or other disorder that compromises the subject's ability to provide informed consent, follow study protocol, or adhere to study treatment","ALL","18 Years","75 Years",{"count":51,"type":52},300,"ESTIMATED","INTERVENTIONAL",[55],"PHASE3","This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.",[58,59,60,61,62],"Pulmonary Arterial Hypertension","Pulmonary Arterial Hypertension (PAH)","Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)","Pulmonary Arterial Hypertension PAH","Pulmonary Arterial Hypertension WHO Group I",[64,58],"PAH","NOT_YET_RECRUITING","2026-05-22",{"date":68,"type":69},"2026-05-29","ACTUAL",{"date":68,"type":52},{"date":72,"type":52},"2029-11-30",{"name":5,"class":6}]