{ "metadata": { "Designs": ["Randomized Controlled Trial"], "Types": [], "BriefSummary": "To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4\n weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The\n dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a\n calibrator.", "Abstract": "To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4\n weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The\n dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a\n calibrator.", "Acronym": null, "ArticleId": "Qy3gwKWSoaWRmbmFEQA", "Authors": null, "CochraneID": null, "Confidential": false, "CorporateAuthor": null, "Country": "Bulgaria, Canada, Hungary, Israel, Norway, Slovakia, United Kingdom, United States", "CustomData": null, "DatabaseType": "ClinicalTrials.gov", "DOI": null, "EmbaseAccessionNumber": null, "Emtree": null, "ErrataText": null, "FullTextURL": null, "Institution": null, "ISSN": null, "Issue": null, "JournalTitle": null, "MedlineID": null, "MeSH": "Hypercholesterolemia|Antibodies, Monoclonal", "Pages": null, "ParentChildStatus": null, "ParentID": null, "PublicationDate": "March 21, 2017", "PublicationYear": 2017, "PubType": null, "ReferenceStudy": null, "SecondarySourceID": null, "Source": "Regeneron Pharmaceuticals", "SourceReferenceId": "NCT01926782", "TaStudyDesign": "Randomized", "Title": "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia", "TrialOutcome": null, "Volume": null, "Id": 179246831, "Created": "2020-04-10T14:48:20.4384957Z", "VersionNo": 2, "ExtractData": null, "Digitized": true, "IsRapidExtract": false, "IsUploaded": false }, "design": "Randomized Controlled Trial", "conditions": [{ "label": "Cholesterol Total Increased", "id": "SUE_c" }], "phase": 3, "name": "NCT01926782", "trialIds": ["NCT01926782"], "acronyms": [], "outcomeCount": 156, "id": 179246831, "groups": [ { "Id": "4r", "RefId": "B5|O2~Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin", "OriginalName": "Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin", "N": 37, "age": 59.3, "ageSD": 11.3, "male": 37.83783783783784, "Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"], ["SUNUVb"]] }], "analyzeAs": "Alirocumab", "analyzableScore": 1.0717734625362931, "matchingScore": 0 }, { "Id": "zB", "RefId": "B6|O3~Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin", "OriginalName": "Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin", "N": 146, "age": 59.2, "ageSD": 10.8, "male": 45.205479452054796, "Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"]] }], "analyzeAs": "Statins", "analyzableScore": 1.0717734625362931, "matchingScore": 0 }, { "Id": "3!", "RefId": "B4|O1~Placebo Q2W Without Concomitant Statin", "OriginalName": "Placebo Q2W Without Concomitant Statin", "N": 73, "age": 59.4, "ageSD": 10.2, "male": 54.794520547945204, "Interventions": [{ "termIds": [["SUGeLS"], ["SUBYEL", "SUB_Oc"]] }], "analyzeAs": "Control", "analyzableScore": 1.2020833333333334, "matchingScore": 0 }, { "Id": "tv", "RefId": "E3", "OriginalName": "Alirocumab 300 mg Q4W/Up 150 mg Q2W", "Interventions": [{ "termIds": [["SUCO54", "SUNUVb"]] }] }, { "Id": "jt", "RefId": "B3|O3~Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin", "OriginalName": "Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin", "N": 312, "age": 61.6, "ageSD": 10, "male": 60.8974358974359, "Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"]] }] }, { "Id": "5!", "RefId": "E2", "OriginalName": "Alirocumab 75 mg Q2W/Up 150 mg Q2W", "Interventions": [{ "termIds": [["SUNUVb"]] }] }, { "Id": "4E", "RefId": "B2|O2~Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin", "OriginalName": "Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin", "N": 78, "age": 60.7, "ageSD": 9.1, "male": 65.38461538461539, "Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"], ["SUNUVb"]] }] }, { "Id": "i4", "Interventions": [ { "Id": "Ya", "Name": 178613599, "Treatments": [{ "Id": "((", "Phase": "k)" }], "Type": "Drug", "termIds": [["SUGeLS"], ["SUNUVb"]], "terms": [["Placebo"], ["Alirocumab"]] }, { "Id": "o)", "Name": 2159990, "Treatments": [{ "Id": "1$", "Phase": "k)" }], "Type": "Drug", "termIds": [["SUBYEL"]], "terms": [["Statins"]] } ], "RefId": "E1|Placebo Q2W", "OriginalName": "Placebo Q2W" }, { "Id": "Ls", "RefId": "B1|O1~Placebo Q2W With Concomitant Statin", "OriginalName": "Placebo Q2W With Concomitant Statin", "N": 157, "age": 61.6, "ageSD": 9.7, "male": 64.3312101910828, "Interventions": [{ "termIds": [["SUGeLS"], ["SUBYEL", "SUB_Oc"]] }] } ], "hasDocData": true, "hasRapidExtract": false, "N": 803, "queryScore": 1.4868329805051381, "matchingScore": 7.960635921410255, "score": 22.084654254966498, "outcomes": [ { "id": "179246387", "type": "Change", "unit": "%", "termIds": [["SUF0R", "SUBskP"]], "quantifiers": [], "name": "Calculated LDL-C in Not Receiving Concomitant Statin Therapy - On-Treatment Analysis", "cells": [ { "number": -0.4, "unit": "%", "group": "3!", "varType": "se", "N": 70, "se": 2, "sd": 16.73 }, { "number": -54.6, "unit": "%", "group": "4r", "varType": "se", "N": 37, "se": 2.8, "sd": 17.03 }, { "number": -59.4, "unit": "%", "group": "zB", "varType": "se", "N": 141, "se": 1.4, "sd": 16.62 } ], "time": { "Id": 67122072, "Low": { "Value": "Baseline" }, "High": { "Number": 24, "Unit": "wk" }, "Type": "Total", "days": 168, "description": "24wk" }, "score": 2.08, "matchingTerm": "SUF0R", "suggestedPositive": false, "sourceUnit": "%" }, { "id": "179246389", "type": "Change", "unit": "%", "termIds": [["SUF0R", "SUBskP"]], "quantifiers": [], "name": "Calculated LDL-C in Receiving Concomitant Statin Therapy - On-Treatment Analysis", "cells": [ { "number": -0.3, "unit": "%", "group": "Ls", "varType": "se", "N": 151, "se": 2.1, "sd": 25.81 }, { "number": -55.1, "unit": "%", "group": "4E", "varType": "se", "N": 75, "se": 3, "sd": 25.98 }, { "number": -62.3, "unit": "%", "group": "jt", "varType": "se", "N": 302, "se": 1.5, "sd": 26.07 } ], "time": { "Id": 67122072, "Low": { "Value": "Baseline" }, "High": { "Number": 24, "Unit": "wk" }, "Type": "Total", "days": 168, "description": "24wk" }, "score": 2.08, "matchingTerm": "SUF0R", "suggestedPositive": false, "sourceUnit": "%" }, { "id": "179246393", "type": "Change", "unit": "%", "termIds": [["SUF0R", "SUBskP"]], "quantifiers": [], "name": "Calculated LDL-C in Not Receiving Concomitant Statin Therapy - On-Treatment Analysis", "cells": [ { "number": -0.5, "unit": "%", "group": "3!", "varType": "se", "N": 70, "se": 2, "sd": 16.73 }, { "number": -53.9, "unit": "%", "group": "4r", "varType": "se", "N": 37, "se": 2.7, "sd": 16.42 }, { "number": -60, "unit": "%", "group": "zB", "varType": "se", "N": 141, "se": 1.4, "sd": 16.62 } ], "time": { "Id": 67122069, "Low": { "Value": "Baseline" }, "High": { "Number": 12, "Unit": "wk" }, "Type": "Total", "days": 84, "description": "12wk" }, "score": 2.08, "matchingTerm": "SUF0R", "suggestedPositive": false, "sourceUnit": "%" }, { "id": "179246394", "type": "Change", "unit": "%", "termIds": [["SUF0R", "SUBskP"]], "quantifiers": [], "name": "Calculated LDL-C in Receiving Concomitant Statin Therapy - On-Treatment Analysis", "cells": [ { "number": 1.4, "unit": "%", "group": "Ls", "varType": "se", "N": 151, "se": 1.9, "sd": 23.35 }, { "number": -47.3, "unit": "%", "group": "4E", "varType": "se", "N": 75, "se": 2.8, "sd": 24.25 }, { "number": -58, "unit": "%", "group": "jt", "varType": "se", "N": 302, "se": 1.4, "sd": 24.33 } ], "time": { "Id": 67122069, "Low": { "Value": "Baseline" }, "High": { "Number": 12, "Unit": "wk" }, "Type": "Total", "days": 84, "description": "12wk" }, "score": 2.08, "matchingTerm": "SUF0R", "suggestedPositive": false, "sourceUnit": "%" } ], "characteristics": [ { "id": "179246354", "type": "Binary", "isCharacteristic": true, "termIds": [["SUE_c", "SUCbN", "SUyJj"]], "quantifiers": [], "name": "Patients not having adequate control of their hypercholesterolemia based on their individual level of CVD risk", "cells": [], "number": 100 } ], "outcomesScore": 18.97947630112307}