{ "FullStudy":{ "Rank":217810, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516541", "OrgStudyIdInfo":{ "OrgStudyId":"NC25608" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-001891-21", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Hoffmann-La Roche", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease", "OfficialTitle":"A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD)." }, "StatusModule":{ "StatusVerifiedDate":"November 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"July 8, 2016", "DispFirstSubmitQCDate":"July 8, 2016", "DispFirstPostDateStruct":{ "DispFirstPostDate":"July 12, 2016", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 1, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 2, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Hoffmann-La Roche", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"2220", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Dalcetrapib", "ArmGroupType":"Experimental", "ArmGroupDescription":"Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Background care", "Drug: dalcetrapib" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo orally daily, on a background of contemporary, guidelines-based medical care.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Background care", "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"Background care", "InterventionDescription":"Guidelines-based medical care", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Dalcetrapib", "Placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Matching dalcetrapib placebo orally daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"dalcetrapib", "InterventionDescription":"600 mg orally daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Dalcetrapib" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ 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