[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637946":3},{"organization":4,"armGroups":7,"interventions":53,"overallOfficials":59,"centralContacts":101,"locations":59,"responsibleParty":107,"collaborators":59,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":59,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":59,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":129,"whyStopped":59,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":59},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,15,22,27,32,37,42,47],{"label":9,"type":10,"description":11,"interventionNames":12},"laroprovstat\u002Frosuvastatin dose 1","EXPERIMENTAL","Patient will receive a daily dose of laroprovstat\u002Frosuvastatin 1 and a placebo to match rosuvastatin 1",[13,14],"Combination Product: laroprovstat\u002Frosuvastatin 1","Drug: Placebo to match Rosuvastatin",{"label":16,"type":17,"description":18,"interventionNames":19},"rosuvastatin dose 1","ACTIVE_COMPARATOR","Patient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat\u002Frosuvastatin 1",[20,21],"Drug: Placebo to match laroprovstat\u002Frosuvastatin 1,2,3","Drug: Rosuvastatin 1",{"label":23,"type":10,"description":24,"interventionNames":25},"laroprovstat\u002Frosuvastatin dose 2","Patient will receive a daily dose of laroprovstat\u002Frosuvastatin 2 and a placebo to match rosuvastatin 2",[26,14],"Combination Product: laroprovstat\u002Frosuvastatin 2",{"label":28,"type":17,"description":29,"interventionNames":30},"rosuvastatin dose 2","Patient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat\u002Frosuvastatin 2",[20,31],"Drug: Rosuvastatin 2",{"label":33,"type":10,"description":34,"interventionNames":35},"laroprovstat\u002Frosuvastatin dose 3","Patient will receive a daily dose of laroprovstat\u002Frosuvastatin 3 and a placebo to match rosuvastatin 3",[36,14],"Combination Product: laroprovstat\u002Frosuvastatin 3",{"label":38,"type":17,"description":39,"interventionNames":40},"rosuvastatin dose 3","Patient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat\u002Frosuvastatin 3",[20,41],"Drug: Rosuvastatin 3",{"label":43,"type":10,"description":44,"interventionNames":45},"laroprovstat\u002Frosuvastatin dose 4","Patient will receive a daily dose of laroprovstat\u002Frosuvastatin 4 and a placebo to match rosuvastatin 4",[46,14],"Combination Product: laroprovstat\u002Frosuvastatin 4",{"label":48,"type":17,"description":49,"interventionNames":50},"rosuvastatin dose 4","Patient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat\u002Frosuvastatin 4",[51,52],"Drug: Placebo to match laroprovstat\u002Frosuvastatin 4","Drug: Rosuvastatin 4",[54,60,64,68,72,77,81,85,89,93,97],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"COMBINATION_PRODUCT","laroprovstat\u002Frosuvastatin 1","daily oral dose of the laroprovstat\u002Frosuvastatin 1",[9],null,{"type":55,"name":61,"description":62,"armGroupLabels":63,"otherNames":59},"laroprovstat\u002Frosuvastatin 2","daily oral dose of the laroprovstat\u002Frosuvastatin 2",[23],{"type":55,"name":65,"description":66,"armGroupLabels":67,"otherNames":59},"laroprovstat\u002Frosuvastatin 3","daily oral dose of the laroprovstat\u002Frosuvastatin 3",[33],{"type":55,"name":69,"description":70,"armGroupLabels":71,"otherNames":59},"laroprovstat\u002Frosuvastatin 4","daily oral dose of the laroprovstat\u002Frosuvastatin 4",[43],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":59},"DRUG","Placebo to match laroprovstat\u002Frosuvastatin 1,2,3","Daily oral dose of placebo to match FDC laroprovstat\u002Frosuvastatin 1,2,3",[16,28,38],{"type":73,"name":78,"description":79,"armGroupLabels":80,"otherNames":59},"Placebo to match laroprovstat\u002Frosuvastatin 4","Daily oral dose of placebo to match FDC laroprovstat\u002Frosuvastatin 4",[48],{"type":73,"name":82,"description":83,"armGroupLabels":84,"otherNames":59},"Rosuvastatin 1","daily oral dose of rosuvastatin 1",[16],{"type":73,"name":86,"description":87,"armGroupLabels":88,"otherNames":59},"Rosuvastatin 2","daily oral dose of rosuvastatin 2",[28],{"type":73,"name":90,"description":91,"armGroupLabels":92,"otherNames":59},"Rosuvastatin 3","daily oral dose of rosuvastatin 3",[38],{"type":73,"name":94,"description":95,"armGroupLabels":96,"otherNames":59},"Rosuvastatin 4","daily oral dose of rosuvastatin 4",[48],{"type":73,"name":98,"description":99,"armGroupLabels":100,"otherNames":59},"Placebo to match Rosuvastatin","daily oral dose of placebo to match rosuvastatin",[9,23,33,43],[102],{"name":103,"role":104,"phone":105,"phoneExt":59,"email":106},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",{"type":108,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR","100637946","phase-3-a-phase-iii-study-to-assess-the-effect-of-fdc-laroprovstatrosuvastatin-compared-with-rosuvastatin-on-ldl-c-in-patients-with-hypercholesterolaemia-100637946",false,"NCT07619118","A Phase III Study to Assess the Effect of FDC Laroprovstat\u002FRosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia","A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat\u002FRosuvastatin Compared With Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients With Hypercholesterolaemia","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age\n* Participants must be on a stable dose of all background LLTs\n* The stable statin dose should be judged as their maximally tolerated dose\n* Participants should have either history of a clinical ASCVD event or be at increased risk for a first clinical ASCVD event\n\nExclusion Criteria:\n\n* Asian origin\n* Uncontrolled severe hypertension\n* Uncontrolled T2DM\n* Inadequately treated hypothyroidism","ALL","18 Years","130 Years",{"count":120,"type":121},200,"ESTIMATED","INTERVENTIONAL",[124],"PHASE3","The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat\u002Frosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic cardiovascular disease (ASCVD) event or at increased risk for a first clinical ASCVD event.",[127],"Hypercholesterolaemia",[127],"NOT_YET_RECRUITING","2026-05-26",{"date":132,"type":133},"2026-06-01","ACTUAL",{"date":135,"type":121},"2026-09-15",{"date":137,"type":121},"2027-05-28",{"name":5,"class":6}]