{ "FullStudy":{ "Rank":217969, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514461", "OrgStudyIdInfo":{ "OrgStudyId":"CLCQ908B2302" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-005535-68", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Novartis", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome", "OfficialTitle":"A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome" }, "StatusModule":{ "StatusVerifiedDate":"May 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"July 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 21, 2011", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"May 15, 2015", "ResultsFirstSubmitQCDate":"May 15, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"June 3, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 15, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 3, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Novartis Pharmaceuticals", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia [HLP] type I). Data from this study will be used to support a registration submission of LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Familial Chylomicronemia Syndrome (FCS)" ] }, "KeywordList":{ "Keyword":[ "Hyperlipoproteinemia (HLP Type I)", "Fasting Triglycerides" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"45", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"LCQ908 20 mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed.\n\nIn period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily.\n\nA low fat diet will be followed and recorded in patient diary.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: LCQ908", "Drug: Placebo" ] } },{ "ArmGroupLabel":"LCQ908 40 mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed.\n\nIn period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily.\n\nA low fat diet will be followed and recorded in patient diary.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: LCQ908", "Drug: Placebo" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily.\n\nIn period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily.\n\nA low fat diet will be followed and recorded in patient diary.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"LCQ908", "InterventionDescription":"LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "LCQ908 20 mg", "LCQ908 40 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "LCQ908 20 mg", "LCQ908 40 mg", "Placebo" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "LCQ908" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percent Change in Fasting Triglycerides From Baseline to 12 Weeks", "PrimaryOutcomeDescription":"Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline.", "PrimaryOutcomeTimeFrame":"Baseline to 12 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL)", "SecondaryOutcomeDescription":"Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.", "SecondaryOutcomeTimeFrame":"Baseline, 12 weeks, 24 weeks, 52 weeks" },{ "SecondaryOutcomeMeasure":"Percentage of Patients Responding to Investigational Treatment by Achieving Final Fasting Triglycerides < 8.4 mmol/L (750 mg/dL)", "SecondaryOutcomeDescription":"Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.", "SecondaryOutcomeTimeFrame":"12 weeks, 24 weeks, 52 weeks" },{ "SecondaryOutcomeMeasure":"Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline", "SecondaryOutcomeDescription":"Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.", "SecondaryOutcomeTimeFrame":"Baseline, 12 weeks, 24 weeks, 52 weeks" },{ "SecondaryOutcomeMeasure":"Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds", "SecondaryOutcomeDescription":"Percentage of patients reaching target values of <1000 mg/dL or target values of < 2000 mg/dL for fasting triglycerides is reported. Pecentage calculated as (m/n)*100; where 'm' The number of patients who reach target values for fasting triglyceride, 'n' the number of patients with non-missing fasting triglyceride.", "SecondaryOutcomeTimeFrame":"12 weeks, 24 weeks, 52 weeks" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline in Fasting Triglycerides", "SecondaryOutcomeTimeFrame":"Baseline, 24 weeks, 52 weeks" },{ "SecondaryOutcomeMeasure":"Percent Change From Baseline for Postprandial Triglycerides Following the Standardized Meal Tolerance Test at Week 12", "SecondaryOutcomeDescription":"Post prandial peak triglycerides - maximum triglyceride value over 0-24 hours Post prandial triglycerides AUC0-24 - area under the time curve for triglycerides over 0-24 Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressed as a percentage change from baseline. hours", "SecondaryOutcomeTimeFrame":"0-24 hours at Baseline, Week 12" },{ "SecondaryOutcomeMeasure":"Pharmacokinetics of LCQ908 - Trough Concentration (Cmin) and Observed Maximum Blood Concentration (Cmax)", "SecondaryOutcomeDescription":"Lowest observed blood concentration (Cmin) and observed maximum blood concentration (Cmax) following drug administration derived from non-compartmental analysis using scheduled sampling time for the whole dataset.", "SecondaryOutcomeTimeFrame":"0, 1, 2, 3, 4, 6, and 24 hours at Week 12" },{ "SecondaryOutcomeMeasure":"Pharmacokinetics of LCQ908- Area Under the Plasma Concentration Time Curve AUC (0-24hour)", "SecondaryOutcomeDescription":"The area under the concentration-time curve from time zero to 24 hours after drug administration was calculated by using linear trapezoidal rule.", "SecondaryOutcomeTimeFrame":"0, 1, 2, 3, 4, 6, and 24 hours at Week 12" },{ "SecondaryOutcomeMeasure":"Pharmacokinetics of LCQ908- Time to Reach Maximum Concentration Following Drug Administration Tmax (Hours)", "SecondaryOutcomeTimeFrame":"0, 1, 2, 3, 4, 6, and 24 hours at Week 12" },{ "SecondaryOutcomeMeasure":"Pharmacokinetics of LCQ908- Average Observed Blood Concentration (Cavg)", "SecondaryOutcomeDescription":"Average observed blood concentration measured by (AUC0-24)/24.", "SecondaryOutcomeTimeFrame":"0, 1, 2, 3, 4, 6, and 24 hours at Week 12" },{ "SecondaryOutcomeMeasure":"Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death", "SecondaryOutcomeTimeFrame":"52 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Key Inclusion Criteria:\n\nWritten informed consent given before any assessment was performed for Period I.\nMale and female patients ages at least 18 years of age.\nFasting triglyceride ≥ 8.4 mmol/L (750 mg/dL) at Screening.\n\nAn established diagnosis of FCS (HLP Type I) confirmed through ultracentrifugation or by documented medical history of a fasting triglyceride ≥ 8.4 mmol/L (750 mg/dL) and by documentation of any of the following at Screening or during the Screening Period:\n\nConfirmed homozygote or compound heterozygote for known loss-of-function mutations in Type I-causing genes (such as LPL, apo C II, GPIHBP1, or LMF1)\nPost heparin plasma LPL activity of ≤ 20% of normal\nConfirmed presence of LPL inactivating antibodies\nHistory of pancreatitis.\n\nKey Exclusion Criteria:\n\nCurrent pancreatitis, pancreatitis was required to be inactive for at least 1 week prior to the screening Visit.\nTreatment with fish oil preparations within 4 weeks prior to randomization.\nTreatment with bile acid binding resins (i.e., colesevelam, etc.) within 4 weeks prior to randomization.\nTreatment with fibrates within 4 weeks prior to randomization.\nGlybera [alipogene tiparvovec (AAV1-LPLS447X)] gene therapy exposure within the two years prior to screening.\nHistory of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\nAny surgical or medical conditions, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study or might significantly alter the absorption, distribution, metabolism or excretion of the study drug.\nHistory of drug or alcohol abuse within the 12 months prior to randomization or evidence of such abuse at screening.\nEvidence of liver disease or liver injury as indicated by abnormal liver function tests such as aspartate aminotransferase (AST) and alanine aminotransferase (ALT), or serum bilirubin.\nEstimated glomerular filtration rate (eGFR) <30mL/min/1.73m2 or history of chronic renal disease.\nParticipation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, or any other limitation of participation based on local regulations.\nHistory of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.\nPregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG laboratory test.\nWomen of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 100 days after discontinuation of investigational study drug.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Novartis Pharmaceuticals", "OverallOfficialAffiliation":"Novartis Pharmaceuticals", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Novartis Investigative Site", "LocationCity":"Seatlle", "LocationState":"Washington", "LocationZip":"98104", "LocationCountry":"United States" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Chicoutimi", "LocationState":"Quebec", "LocationZip":"G7H 7P2", "LocationCountry":"Canada" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Ste-Foy", "LocationState":"Quebec", "LocationZip":"G1V4M6", "LocationCountry":"Canada" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Ouest-Montreal", "LocationZip":"H2W1R7", "LocationCountry":"Canada" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Bron", "LocationZip":"69677", "LocationCountry":"France" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Nantes", "LocationZip":"44093", "LocationCountry":"France" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Paris Cedex 13", "LocationZip":"75651", "LocationCountry":"France" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Hamburg", "LocationZip":"20246", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Köln", "LocationZip":"50937", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Meibergdreef 9", "LocationZip":"1105 AZ", "LocationCountry":"Netherlands" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Cape Town", "LocationZip":"7925", "LocationCountry":"South Africa" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Malaga", "LocationState":"Andalucia", "LocationZip":"29010", "LocationCountry":"Spain" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Sevilla", "LocationState":"Andalucia", "LocationZip":"41013", "LocationCountry":"Spain" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Manchester", "LocationZip":"M13 9NT", "LocationCountry":"United Kingdom" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"LCQ908 20 mg", "FlowGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"LCQ908 40 mg", "FlowGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"15" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"15" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"15" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"10" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"12" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"11" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"5" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"4" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Physician Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Patient/guardian decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"LCQ908 20 mg", "BaselineGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"LCQ908 40 mg", "BaselineGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"15" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"15" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"15" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"45" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"52.9", "BaselineMeasurementSpread":"10.9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"42.3", "BaselineMeasurementSpread":"13.61" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"42.7", "BaselineMeasurementSpread":"10.94" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"45.9", "BaselineMeasurementSpread":"12.63" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"< 65 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"42" } ] } } ] } },{ "BaselineClassTitle":">=65 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"19" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"26" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percent Change in Fasting Triglycerides From Baseline to 12 Weeks", "OutcomeMeasureDescription":"Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. The number of randomized patients with non-missing fasting triglycerides values at baseline and Week 12 are included in this analysis.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percent change", "OutcomeMeasureTimeFrame":"Baseline to 12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 20mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"45.6", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"98.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.7", "OutcomeMeasurementLowerLimit":"-24.3", "OutcomeMeasurementUpperLimit":"42.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-13.9", "OutcomeMeasurementLowerLimit":"-38.9", "OutcomeMeasurementUpperLimit":"21.3" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0538", "OutcomeAnalysisStatisticalMethod":"Mixed Models Analysis", "OutcomeAnalysisStatisticalComment":"Mixed Model of Repeated Measurements", "OutcomeAnalysisParamType":"% change from reference treatment", "OutcomeAnalysisParamValue":"-28.78", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-55.69", "OutcomeAnalysisCIUpperLimit":"14.46" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0182", "OutcomeAnalysisStatisticalMethod":"Mixed Models Analysis", "OutcomeAnalysisStatisticalComment":"Mixed Model of Repeated Measurements", "OutcomeAnalysisParamType":"% change from reference treatment", "OutcomeAnalysisParamValue":"-40.88", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-63.99", "OutcomeAnalysisCIUpperLimit":"-2.94" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL)", "OutcomeMeasureDescription":"Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Baseline, 12 weeks, 24 weeks, 52 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 20 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 12 (n = 14, 14, 12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"21.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"50.0" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n = 13, 14, 12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"35.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"33.3" } ] } } ] } },{ "OutcomeClassTitle":"Week 52 (n = 11, 14, 11)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"18.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"21.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"27.3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Patients Responding to Investigational Treatment by Achieving Final Fasting Triglycerides < 8.4 mmol/L (750 mg/dL)", "OutcomeMeasureDescription":"Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12 weeks, 24 weeks, 52 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 20 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 12 (n = 14, 14, 12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"33.3" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n = 13, 14, 12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"16.7" } ] } } ] } },{ "OutcomeClassTitle":"Week 52 (n = 11, 14, 11)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"18.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"18.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline", "OutcomeMeasureDescription":"Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Baseline, 12 weeks, 24 weeks, 52 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 20 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 12 (n = 14, 14, 12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"25.0" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n = 13, 14, 12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"28.6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"16.7" } ] } } ] } },{ "OutcomeClassTitle":"Week 52 (n = 11, 14, 11)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"27.3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds", "OutcomeMeasureDescription":"Percentage of patients reaching target values of <1000 mg/dL or target values of < 2000 mg/dL for fasting triglycerides is reported. Pecentage calculated as (m/n)*100; where 'm' The number of patients who reach target values for fasting triglyceride, 'n' the number of patients with non-missing fasting triglyceride.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of patients", "OutcomeMeasureTimeFrame":"12 weeks, 24 weeks, 52 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 20 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"TG < 1000 mg/dL, week 12 (n=14,14,12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"21.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"33.3" } ] } } ] } },{ "OutcomeClassTitle":"TG < 1000 mg/dL, week 24 (n=13,14,12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"21.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"25.0" } ] } } ] } },{ "OutcomeClassTitle":"TG < 1000 mg/dL, week 52 (n=11,14,11)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"27.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"36.4" } ] } } ] } },{ "OutcomeClassTitle":"TG < 2000 mg/dL, week 12 (n=14,14,12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"35.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"50.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"83.3" } ] } } ] } },{ "OutcomeClassTitle":"TG < 2000 mg/dL, week 24 (n=13,14,12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"38.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"57.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"58.3" } ] } } ] } },{ "OutcomeClassTitle":"TG < 2000 mg/dL, week 52 (n=11,14,11)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"36.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"50.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"63.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percent Change From Baseline in Fasting Triglycerides", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percent change", "OutcomeMeasureTimeFrame":"Baseline, 24 weeks, 52 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 20 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 24 (n=13, 14, 12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.9", "OutcomeMeasurementLowerLimit":"-26.6", "OutcomeMeasurementUpperLimit":"50.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-15.8", "OutcomeMeasurementLowerLimit":"-40.5", "OutcomeMeasurementUpperLimit":"19.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5.5", "OutcomeMeasurementLowerLimit":"-28.0", "OutcomeMeasurementUpperLimit":"54.5" } ] } } ] } },{ "OutcomeClassTitle":"Week 52 (n=11, 14, 11)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.2", "OutcomeMeasurementLowerLimit":"-23.0", "OutcomeMeasurementUpperLimit":"72.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-6.7", "OutcomeMeasurementLowerLimit":"-36.4", "OutcomeMeasurementUpperLimit":"36.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.9", "OutcomeMeasurementLowerLimit":"-31.2", "OutcomeMeasurementUpperLimit":"60.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percent Change From Baseline for Postprandial Triglycerides Following the Standardized Meal Tolerance Test at Week 12", "OutcomeMeasureDescription":"Post prandial peak triglycerides - maximum triglyceride value over 0-24 hours Post prandial triglycerides AUC0-24 - area under the time curve for triglycerides over 0-24 Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressed as a percentage change from baseline. hours", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. For each category, the number of randomized patients who have non-missing values are included in this analysis.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percent change", "OutcomeMeasureTimeFrame":"0-24 hours at Baseline, Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 20 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Triglycerides (Peak 0-24h) [n=12, 12, 11)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"56.9", "OutcomeMeasurementLowerLimit":"6.9", "OutcomeMeasurementUpperLimit":"130.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.6", "OutcomeMeasurementLowerLimit":"-24.8", "OutcomeMeasurementUpperLimit":"56.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6.3", "OutcomeMeasurementLowerLimit":"-30.3", "OutcomeMeasurementUpperLimit":"62.2" } ] } } ] } },{ "OutcomeClassTitle":"Triglycerides (AUC 0-24h) [n=12, 12, 11)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"44.5", "OutcomeMeasurementLowerLimit":"-1.3", "OutcomeMeasurementUpperLimit":"111.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.8", "OutcomeMeasurementLowerLimit":"-30.1", "OutcomeMeasurementUpperLimit":"45.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.8", "OutcomeMeasurementLowerLimit":"-32.4", "OutcomeMeasurementUpperLimit":"56.3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Pharmacokinetics of LCQ908 - Trough Concentration (Cmin) and Observed Maximum Blood Concentration (Cmax)", "OutcomeMeasureDescription":"Lowest observed blood concentration (Cmin) and observed maximum blood concentration (Cmax) following drug administration derived from non-compartmental analysis using scheduled sampling time for the whole dataset.", "OutcomeMeasurePopulationDescription":"Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng/mL", "OutcomeMeasureTimeFrame":"0, 1, 2, 3, 4, 6, and 24 hours at Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LCQ908 20 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Cmin", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"312", "OutcomeMeasurementSpread":"120" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"426", "OutcomeMeasurementSpread":"224" } ] } } ] } },{ "OutcomeClassTitle":"Cmax", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"603", "OutcomeMeasurementSpread":"244" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"745", "OutcomeMeasurementSpread":"408" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Pharmacokinetics of LCQ908- Area Under the Plasma Concentration Time Curve AUC (0-24hour)", "OutcomeMeasureDescription":"The area under the concentration-time curve from time zero to 24 hours after drug administration was calculated by using linear trapezoidal rule.", "OutcomeMeasurePopulationDescription":"Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng/mL *hr", "OutcomeMeasureTimeFrame":"0, 1, 2, 3, 4, 6, and 24 hours at Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LCQ908 20 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11000", "OutcomeMeasurementSpread":"4100" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14300", "OutcomeMeasurementSpread":"7390" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Pharmacokinetics of LCQ908- Time to Reach Maximum Concentration Following Drug Administration Tmax (Hours)", "OutcomeMeasurePopulationDescription":"Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"hours", "OutcomeMeasureTimeFrame":"0, 1, 2, 3, 4, 6, and 24 hours at Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LCQ908 20 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"24" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"24" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Pharmacokinetics of LCQ908- Average Observed Blood Concentration (Cavg)", "OutcomeMeasureDescription":"Average observed blood concentration measured by (AUC0-24)/24.", "OutcomeMeasurePopulationDescription":"Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng/mL", "OutcomeMeasureTimeFrame":"0, 1, 2, 3, 4, 6, and 24 hours at Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LCQ908 20 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"459", "OutcomeMeasurementSpread":"171" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"597", "OutcomeMeasurementSpread":"308" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death", "OutcomeMeasurePopulationDescription":"Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"52 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"LCQ908 20 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"LCQ908 40 mg", "OutcomeGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"14" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"At least one adverse events", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"14" } ] } } ] } },{ "OutcomeClassTitle":"At least one serious adverse event", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Death", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsDescription":"Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Placebo", "EventGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.", "EventGroupSeriousNumAffected":"6", "EventGroupSeriousNumAtRisk":"15", "EventGroupOtherNumAffected":"15", "EventGroupOtherNumAtRisk":"15" },{ "EventGroupId":"EG001", "EventGroupTitle":"LCQ908 20 mg", "EventGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary.", "EventGroupSeriousNumAffected":"6", "EventGroupSeriousNumAtRisk":"15", "EventGroupOtherNumAffected":"15", "EventGroupOtherNumAtRisk":"15" },{ "EventGroupId":"EG002", "EventGroupTitle":"LCQ908 40 mg", "EventGroupDescription":"In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.", "EventGroupSeriousNumAffected":"3", "EventGroupSeriousNumAtRisk":"14", "EventGroupOtherNumAffected":"14", "EventGroupOtherNumAtRisk":"14" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"CARDIAC ARREST", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"ABDOMINAL PAIN", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"GASTROINTESTINAL DISORDER", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"PANCREATITIS", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"PANCREATITIS ACUTE", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"HYPERTRANSAMINASAEMIA", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"PNEUMONIA", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"INCISIONAL HERNIA", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"HEPATIC ENZYME INCREASED", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"HYPERGLYCAEMIA", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"MALIGNANT PALATE NEOPLASM", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"CEREBRAL HAEMORRHAGE", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"PULMONARY EMBOLISM", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"FEMORAL ARTERY OCCLUSION", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"ANAEMIA", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"15" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"15" 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