{ "FullStudy":{ "Rank":217626, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518946", "OrgStudyIdInfo":{ "OrgStudyId":"SPD426-406" }, "Organization":{ "OrgFullName":"Shire", "OrgClass":"INDUSTRY" }, "BriefTitle":"Tilt-Table Study of the Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension", "OfficialTitle":"A Phase 4, Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Clinical Benefit of Midodrine Hydrochloride in Male and Female Subjects With Symptomatic Orthostatic Hypotension" }, "StatusModule":{ "StatusVerifiedDate":"December 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 14, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 22, 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 22, 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"July 3, 2014", "ResultsFirstSubmitQCDate":"July 3, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"July 31, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 17, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 9, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Shire", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine whether midodrine works against the symptoms of orthostatic hypotension caused by being on a tilt table.", "DetailedDescription":"The efficacy of midodrine will be assessed in those subjects who have severe symptoms of orthostatic hypotension when not taking midodrine and are controlled when taking midodrine. The study will involve approximately 4 overnight stays." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Orthostatic Hypotension" ] }, "KeywordList":{ "Keyword":[ "Symptomatic Orthostatic Hypotension" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"24", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Midodrine HCl", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Midodrine HCl" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Midodrine HCl", "InterventionDescription":"dose at the subject's current dose level", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Midodrine HCl" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "ProAmatine®" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"single dose of matching placebo", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Time to Onset of Syncope/Near Syncope While on Tilt Table", "PrimaryOutcomeDescription":"After a 30-minute supine period, the table was tilted from 0-90º within 30 seconds and maintained in that position for 45 minutes or until endpoint. Subjects were monitored for near-syncopal symptoms (subject felt sufficiently dizzy, lightheaded, faint, or felt like they were about to black out and requested the table to be returned to horizontal). Such a report ended the test. Alternatively, if the investigator observed that the subject was about to lose consciousness, that also constituted an endpoint.", "PrimaryOutcomeTimeFrame":"1 hour post-dose" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale and female subjects must be 18 years of age or older and ambulatory.\nFemales of child-bearing potential (FOCP) must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test.\nA documented history of severe Symptomatic Orthostatic Hypotension (SOH) that, in the judgment of the treating physician, has required treatment with midodrine HCl , and has been at a stable dose for at least 3 months.\nThe subject has manifested at least 1 of the following symptoms while standing or had a medical history of 1 of the following when not treated for orthostatic hypotension (OH): dizziness, lightheadedness, feeling faint, or feeling like they might black out.\n\nExclusion Criteria:\n\nThe subject is a pregnant or lactating female.\nThe subject has pre-existing sustained supine hypertension greater than 180mmHg systolic and 110mmHg diastolic BP or had these measurements at the Screening Visit. Sustained is defined as persistently greater at 2 separate measurements at least 5 minutes apart with the subject supine and at rest for the 5 minutes.\nSubjects taking concomitant medications of interest are excluded unless those medications are reviewed and discussed with the Medical Monitor or Study Physician and documented prior to enrolling the subject. If agreement is reached between the Investigator and Sponsor for the subject to continue in the study, all allowed medications should be maintained at a constant dose throughout the study.\nThe Principal Investigator deems any clinical laboratory test (at the Screening Visit) abnormality to be clinically significant\nThe subject has participated in other studies of investigational drugs or devices within 30 days prior to enrollment in this study (other than Study SPD426-406).\nCurrent or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.\nThe subject has a concurrent chronic or acute illness, disability, or other condition (including significant unexpected laboratory or electrocardiogram [ECG] findings) that might confound the results of the tests and/or measurements administered in this study, or that might have increased the risk to the subject.\nKnown or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients.\nPrior enrollment failure or randomization in this study.\nHistory of alcohol abuse or other substance abuse within the last year.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Study Director", "OverallOfficialAffiliation":"Shire", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Parkinson's Disease and Movement Disorders Center of Boca Raton", "LocationCity":"Boca Raton", "LocationState":"Florida", "LocationZip":"33486", "LocationCountry":"United States" },{ "LocationFacility":"Advance Research Institute Inc", "LocationCity":"New Port Richey", "LocationState":"Florida", "LocationZip":"34653", "LocationCountry":"United States" },{ "LocationFacility":"Analab Clinical Research Inc", "LocationCity":"Lenexa", "LocationState":"Kansas", "LocationZip":"66219", "LocationCountry":"United States" },{ "LocationFacility":"Mayo Clinic", "LocationCity":"Rochester", "LocationState":"Minnesota", "LocationZip":"55905", "LocationCountry":"United States" },{ "LocationFacility":"Buffalo Clinical Research Center (BCRC)", "LocationCity":"Buffalo", "LocationState":"New York", "LocationZip":"14202", "LocationCountry":"United States" },{ "LocationFacility":"NYU Medical Centre", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"10016", "LocationCountry":"United States" },{ "LocationFacility":"Columbia University", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"10032", "LocationCountry":"United States" },{ "LocationFacility":"Cleveland Clinic", "LocationCity":"Cleveland", "LocationState":"Ohio", "LocationZip":"44195", "LocationCountry":"United States" },{ "LocationFacility":"Kidney and Hypertension Center", "LocationCity":"Roseburg", "LocationState":"Oregon", "LocationZip":"97471", "LocationCountry":"United States" },{ "LocationFacility":"New Orleans Center for Clinical Research - Knoxville", "LocationCity":"Knoxville", "LocationState":"Tennessee", "LocationZip":"37920", "LocationCountry":"United States" },{ "LocationFacility":"The Heartbeat Clinic, PA", "LocationCity":"McKinney", "LocationState":"Texas", "LocationZip":"75069", "LocationCountry":"United States" },{ "LocationFacility":"Aspen Clinical Research", "LocationCity":"Orem", "LocationState":"Utah", "LocationZip":"84058", "LocationCountry":"United States" },{ "LocationFacility":"Aurora Cardiovascular Services", "LocationCity":"Milwaukee", "LocationState":"Wisconsin", "LocationZip":"53215", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"27372462", "ReferenceType":"result", "ReferenceCitation":"Smith W, Wan H, Much D, Robinson AG, Martin P. Clinical benefit of midodrine hydrochloride in symptomatic orthostatic hypotension: a phase 4, double-blind, placebo-controlled, randomized, tilt-table study. Clin Auton Res. 2016 Aug;26(4):269-77. doi: 10.1007/s10286-016-0363-9. Epub 2016 Jul 2." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Midodrine HCl (Open-label Phase)", "FlowGroupDescription":"On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Placebo First, Then Midodrine HCl (Randomized Phase)", "FlowGroupDescription":"Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Midodrine HCl First, Then Placebo (Randomized Phase)", "FlowGroupDescription":"Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Open-label Phase", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"24" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"20" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Randomized Phase (First Intervention)", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"10" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"10" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"10" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Randomized Phase (Second Intervention)", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"10" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"10" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Randomized Safety Analysis Set defined as all subjects who received at least 1 dose of randomized investigational product.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Placebo First, Then Midodrine HCl (Randomized Phase)", "BaselineGroupDescription":"Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Midodrine HCl First, Then Placebo (Randomized Phase)", "BaselineGroupDescription":"Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"10" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"10" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"20" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"48.0", "BaselineMeasurementSpread":"19.52" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"42.1", "BaselineMeasurementSpread":"18.64" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"45.1", "BaselineMeasurementSpread":"18.82" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"18 to 65 years, inclusive", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"16" } ] } } ] } },{ "BaselineClassTitle":">= 66 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" } ] } } ] } } ] } },{ "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":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"18" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"20" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Time to Onset of Syncope/Near Syncope While on Tilt Table", "OutcomeMeasureDescription":"After a 30-minute supine period, the table was tilted from 0-90º within 30 seconds and maintained in that position for 45 minutes or until endpoint. Subjects were monitored for near-syncopal symptoms (subject felt sufficiently dizzy, lightheaded, faint, or felt like they were about to black out and requested the table to be returned to horizontal). Such a report ended the test. Alternatively, if the investigator observed that the subject was about to lose consciousness, that also constituted an endpoint.", "OutcomeMeasurePopulationDescription":"The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of randomized investigational product and who had at least 1 measurement of the time to onset of syncopal symptoms/near syncope during tilt-table testing.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"seconds", "OutcomeMeasureTimeFrame":"1 hour post-dose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"single dose of matching placebo" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Midodrine HCl", "OutcomeGroupDescription":"dose at the subject's current dose level" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"19" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1105.6", "OutcomeMeasurementSpread":"186.82" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1626.6", "OutcomeMeasurementSpread":"186.82" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0131", "OutcomeAnalysisStatisticalMethod":"ANOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"521.0", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"124.2", "OutcomeAnalysisCIUpperLimit":"917.7" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Midodrine HCl (Open-label Phase)", "EventGroupDescription":"dose at the subject's current dose level", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"24", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"24" },{ "EventGroupId":"EG001", "EventGroupTitle":"Placebo (Randomized Phase)", "EventGroupDescription":"single dose of matching placebo", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"20", "EventGroupOtherNumAffected":"1", "EventGroupOtherNumAtRisk":"20" },{ "EventGroupId":"EG002", "EventGroupTitle":"Midodrine HCl (Randomized Phase)", "EventGroupDescription":"dose at the subject's current dose level", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"20", "EventGroupOtherNumAffected":"1", "EventGroupOtherNumAtRisk":"20" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"20" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Fatigue", "OtherEventOrganSystem":"General disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"20" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Back Pain", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"20" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Headache", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"20" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Flushing", "OtherEventOrganSystem":"Vascular disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"20" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Hot Flush", "OtherEventOrganSystem":"Vascular disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"24" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"20" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"20" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually." }, "PointOfContact":{ "PointOfContactTitle":"Study Physician", "PointOfContactOrganization":"Shire", "PointOfContactPhone":"+1 866-842-5335" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "Germany" ] } }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000008879", "InterventionMeshTerm":"Midodrine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000013566", "InterventionAncestorTerm":"Sympathomimetics" },{ "InterventionAncestorId":"D000001337", "InterventionAncestorTerm":"Autonomic Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000014662", "InterventionAncestorTerm":"Vasoconstrictor Agents" },{ "InterventionAncestorId":"D000058646", 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