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7.4 KiB
{"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 - 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