{ "FullStudy":{ "Rank":217862, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515865", "OrgStudyIdInfo":{ "OrgStudyId":"SPD426-405" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2012-005760-99", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Shire", "OrgClass":"INDUSTRY" }, "BriefTitle":"Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension", "OfficialTitle":"A Phase 4, Randomized-withdrawal, Double-blind, Placebo Controlled, Parallel-group Study to Investigate the Clinical Benefit of Midodrine Hydrochloride in Male and Female Subjects With Symptomatic Orthostatic Hypotension" }, "StatusModule":{ "StatusVerifiedDate":"October 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"November 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"October 16, 2014", "ResultsFirstSubmitQCDate":"October 16, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"October 22, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 10, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 21, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Shire", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"To study the effect of midodrine against the symptoms of orthostatic hypotension", "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 9 overnight stays." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Symptomatic Orthostatic Hypotension" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"67", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Midodrine HCl", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Midodrine HCl" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Midodrine HCl", "InterventionDescription":"dose at 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":"Percent of Subjects Who Failed to Maintain a Response", "PrimaryOutcomeDescription":"Failure to maintain a response was defined as any randomized subject that met both criterion 1 and criterion 2 below on Day 16:\n\nThe Orthostatic Hypotension Symptom Assessment (OHSA) Item 1 score increased by >=4 points compared to baseline. OHSA Item 1 is a dizziness scale that is scored on a range from 0 (no dizziness) to 10 (severe dizziness). A lower score indicates less severe symptoms.\nThere was an increase in the number of syncopal/near syncopal events or severity of events within 15 minutes of standing compared to those observed at baseline. Syncope was defined as a loss of consciousness, and near syncope was defined as a feeling (e.g., dizziness, lightheadedness, feeling faint, feeling as though one would black out) that, without intervention, would lead to a loss of consciousness.", "PrimaryOutcomeTimeFrame":"30 minutes post-dose on Day 16" } ] } }, "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":{ "LocationList":{ "Location":[ { "LocationFacility":"California Clinical Trials Medical Group", "LocationCity":"Glendale", "LocationState":"California", "LocationZip":"91206", "LocationCountry":"United States" },{ "LocationFacility":"Pharmaseek-Burbank", "LocationCity":"North Hollywood", "LocationState":"California", "LocationZip":"91606", "LocationCountry":"United States" },{ "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":"DMI Reasearch Inc", "LocationCity":"Pinellas Park", "LocationState":"Florida", "LocationZip":"33782", "LocationCountry":"United States" },{ "LocationFacility":"Parkinson's Disease Treatment Center of Southwest Florida", "LocationCity":"Port Charlotte", "LocationState":"Florida", "LocationZip":"33980", "LocationCountry":"United States" },{ "LocationFacility":"Chicago Medical VA", "LocationCity":"North Chicago", "LocationState":"Illinois", "LocationZip":"60064", "LocationCountry":"United States" },{ "LocationFacility":"Analab Clinical Research Inc", "LocationCity":"Lenexa", "LocationState":"Kansas", "LocationZip":"66219", "LocationCountry":"United States" },{ "LocationFacility":"PAREXEL International - Baltimore EPCU Harbor Hospital", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21225", "LocationCountry":"United States" },{ "LocationFacility":"Frontage Clinical Services", "LocationCity":"Hackensack", "LocationState":"New Jersey", "LocationZip":"07601", "LocationCountry":"United States" },{ "LocationFacility":"Buffalo Clinical Research Center (BCRC)", "LocationCity":"Buffalo", "LocationState":"New York", "LocationZip":"14202", "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":"UT South West Medical Center", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75390", "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":"Fakultní nemocnice Hradec Králové", "LocationCity":"Hradec", "LocationState":"Králové", "LocationZip":"500 05", "LocationCountry":"Czech Republic" },{ "LocationFacility":"Fakultní nemocnice Ostrava", "LocationCity":"Ostrava", "LocationState":"Poruba", "LocationZip":"708 52", "LocationCountry":"Czech Republic" },{ "LocationFacility":"Fakultní nemocnice v Motole", "LocationCity":"Praha", "LocationZip":"150 06", "LocationCountry":"Czech Republic" },{ "LocationFacility":"EMC Silesia Sp. z o.o.; NZOZ Szpital Geriatryczny im. Jana Pawła II w Katowicach", "LocationCity":"Katowice", "LocationZip":"40-353", "LocationCountry":"Poland" },{ "LocationFacility":"Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala, + satelite site:NZOZ Szpital Avimed Sp. z o.o.", "LocationCity":"Katowice", "LocationZip":"40-588", "LocationCountry":"Poland" },{ "LocationFacility":"Centrum Medyczne HCP, Lecznictwo Stacjonarne, Oddział Udarowy", "LocationCity":"Poznań", "LocationZip":"61-485", "LocationCountry":"Poland" },{ "LocationFacility":"MTZ Clinical Research Sp. z o.o.", "LocationCity":"Warszawa", "LocationZip":"02-106", "LocationCountry":"Poland" },{ "LocationFacility":"Wojskowy Instytut Medyczny, Klinika Neurologiczna", "LocationCity":"Warszawa", "LocationZip":"04-141", "LocationCountry":"Poland" },{ "LocationFacility":"Neurologická klinika SZU a UNB, Univerzitná nemocnica Bratislava", "LocationCity":"Bratislava", "LocationZip":"826 06", "LocationCountry":"Slovakia" },{ "LocationFacility":"Neurologická klinika UN Martin, Univerzitná nemocnica Martin", "LocationCity":"Martin", "LocationZip":"036 59", "LocationCountry":"Slovakia" },{ "LocationFacility":"Neurologická klinika FN Nitra, Fakultná nemocnica Nitra", "LocationCity":"Nitra", "LocationZip":"949 01", "LocationCountry":"Slovakia" },{ "LocationFacility":"Neurologické oddelenie, Nemocnica s poliklinikou Spišská Nová Ves, a.s.", "LocationCity":"Spišská Nová Ves", "LocationZip":"052 01", "LocationCountry":"Slovakia" },{ "LocationFacility":"Neurologické oddelenie FN Trnava, Fakultná nemocnica Trnava", "LocationCity":"Trnava", "LocationZip":"917 75", "LocationCountry":"Slovakia" },{ "LocationFacility":"Neurologické oddelenie FNsP Žilina, Fakultná nemocnica s poliklinikou Žilina", "LocationCity":"Žilina", "LocationZip":"012 07", "LocationCountry":"Slovakia" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Subjects received the dose and frequency of Midodrine HCl that they had been receiving during their non-study treatment prior to enrolling in this study.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Midodrine HCl - (Open-label)", "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. On Day 2, all eligible subjects continued on their midodrine HCl dose regimen over at least 14 days, using study-supplied investigational product." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Midodrine HCl - (Randomized)", "FlowGroupDescription":"On Day 16 subjects received over-encapsulated midodrine HCl tablets (equivalent to their previously prescribed dose)." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Placebo - (Randomized)", "FlowGroupDescription":"On Day 16 subjects received matching placebo." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Part A (Open-label)", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"98" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"95" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Part B (Open-label)", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Twenty-four subjects from Part A did not meet the criteria required to be enrolled into Part B.", "FlowAchievementNumSubjects":"71" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"69" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Part C (Randomized)", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"A total of two subjects from Part B did not meet the criteria required to be enrolled into Part C.", "FlowAchievementNumSubjects":"33" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"34" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"33" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"34" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"The Enrolled Population consisted of all subjects who participated in Part A baseline procedures starting at Day -1.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Enrolled Population" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"98" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"45.5", "BaselineMeasurementSpread":"17.45" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"76" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"22" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"90" } ] } } ] } },{ "BaselineClassTitle":"Slovakia", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" } ] } } ] } },{ "BaselineClassTitle":"Poland", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percent of Subjects Who Failed to Maintain a Response", "OutcomeMeasureDescription":"Failure to maintain a response was defined as any randomized subject that met both criterion 1 and criterion 2 below on Day 16:\n\nThe Orthostatic Hypotension Symptom Assessment (OHSA) Item 1 score increased by >=4 points compared to baseline. OHSA Item 1 is a dizziness scale that is scored on a range from 0 (no dizziness) to 10 (severe dizziness). A lower score indicates less severe symptoms.\nThere was an increase in the number of syncopal/near syncopal events or severity of events within 15 minutes of standing compared to those observed at baseline. Syncope was defined as a loss of consciousness, and near syncope was defined as a feeling (e.g., dizziness, lightheadedness, feeling faint, feeling as though one would black out) that, without intervention, would lead to a loss of consciousness.", "OutcomeMeasurePopulationDescription":"The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of double-blind investigational product.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"30 minutes post-dose on Day 16", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Midodrine HCl", "OutcomeGroupDescription":"Over-encapsulated midodrine HCl tablet at the subjects previously prescribed dose level." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Matching placebo treatment (utilizing the same number of placebo capsules that would be required to constitute their midodrine HCl dose)." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"33" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"34" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"44.1" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.3145", "OutcomeAnalysisStatisticalMethod":"Fisher Exact", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-13.8", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-37.6", "OutcomeAnalysisCIUpperLimit":"9.8" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Midodrine HCl - Open-label (Part A)", "EventGroupDescription":"dose at the subjects current dose level", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"98", "EventGroupOtherNumAffected":"5", "EventGroupOtherNumAtRisk":"98" },{ "EventGroupId":"EG001", "EventGroupTitle":"Midodrine HCl - Open-label (Part B)", "EventGroupDescription":"open-label study-supplied (Part B) dose at subjects current dose level", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"71", "EventGroupOtherNumAffected":"2", "EventGroupOtherNumAtRisk":"71" },{ "EventGroupId":"EG002", "EventGroupTitle":"Midodrine HCl - Randomized (Part C)", "EventGroupDescription":"over-encapsulated randomized dose (Part C) at subjects current dose level", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"33", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"33" },{ "EventGroupId":"EG003", "EventGroupTitle":"Placebo - Randomized (Part C)", "EventGroupDescription":"over-encapsulated randomized matching placebo", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"34", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"34" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Headache", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"98" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"71" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"33" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"34" } ] } } ] } }, "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 Development LLC", "PointOfContactPhone":"+1 866 842 5335" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "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", "InterventionAncestorTerm":"Adrenergic alpha-1 Receptor Agonists" },{ "InterventionAncestorId":"D000000316", "InterventionAncestorTerm":"Adrenergic alpha-Agonists" },{ "InterventionAncestorId":"D000000322", 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