Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-02-23 @ 7:59 PM
Study NCT ID:
NCT00549718
Status:
COMPLETED
Last Update Posted:
2014-06-11
First Post:
2007-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069056', 'term': 'Lurasidone Hydrochloride'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'josephine.cucchiaro@sunovion.com', 'phone': '201-592-2050', 'title': 'Josephine Cucchiaro', 'organization': 'Sunovion Pharmaceuticals Inc.'}, 'certainAgreement': {'otherDetails': 'For multi-center studies, it is mandatory that the first publication is based on all data obtained from all analyses as stipulated in the protocol. Investigators participating in multicenter studies must agree not to present data gathered individually or by subgroup of centers before the full, initial publication, unless this has been agreed to by all other investigators and also by DSP-Sepracor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '14 days post study therapy', 'eventGroups': [{'id': 'EG000', 'title': 'Lurasidone 40mg', 'description': 'Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.', 'otherNumAtRisk': 124, 'otherNumAffected': 96, 'seriousNumAtRisk': 124, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Lurasidone 80mg', 'description': 'lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.', 'otherNumAtRisk': 121, 'otherNumAffected': 90, 'seriousNumAtRisk': 121, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Lurasidone 120mg', 'description': 'Lurasidone 40 mg tablets taken once/day', 'otherNumAtRisk': 124, 'otherNumAffected': 106, 'seriousNumAtRisk': 124, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.', 'otherNumAtRisk': 127, 'otherNumAffected': 85, 'seriousNumAtRisk': 127, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Weight Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 65}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Staphylococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Blood Lactate Dehydrogenase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Complex Partial Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Psychotic Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'CGI-S From Baseline to the End of the Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone 40mg', 'description': 'Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.'}, {'id': 'OG001', 'title': 'Lurasidone 80mg', 'description': 'lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.'}, {'id': 'OG002', 'title': 'Lurasidone 120mg', 'description': 'Lurasidone 40 mg tablets taken once/day'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '-0.9'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '-1.2'}, {'value': '-1.2', 'groupId': 'OG002', 'lowerLimit': '-1.4', 'upperLimit': '-1.0'}, {'value': '-1.0', 'groupId': 'OG003', 'lowerLimit': '-1.2', 'upperLimit': '-0.8'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': "Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).", 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population.All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement,were in the efficacy analysis in the treatment group to which they were randomized.', 'anticipatedPostingDate': '2010-10'}, {'type': 'PRIMARY', 'title': 'Change in Total PANSS Score From Baseline to the End of the Double Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone 40mg', 'description': 'Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.'}, {'id': 'OG001', 'title': 'Lurasidone 80mg', 'description': 'lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.'}, {'id': 'OG002', 'title': 'Lurasidone 120mg', 'description': 'Lurasidone 40 mg tablets taken once/day'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.2', 'groupId': 'OG000', 'lowerLimit': '-22.6', 'upperLimit': '-15.7'}, {'value': '-23.4', 'groupId': 'OG001', 'lowerLimit': '-26.9', 'upperLimit': '-19.9'}, {'value': '-20.5', 'groupId': 'OG002', 'lowerLimit': '-24.0', 'upperLimit': '-17.1'}, {'value': '-17.0', 'groupId': 'OG003', 'lowerLimit': '-20.5', 'upperLimit': '-13.6'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.', 'anticipatedPostingDate': '2010-10'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lurasidone 40mg', 'description': 'Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.'}, {'id': 'FG001', 'title': 'Lurasidone 80mg', 'description': 'lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.'}, {'id': 'FG002', 'title': 'Lurasidone 120mg', 'description': 'Lurasidone 40 mg tablets taken once/day'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '124'}, {'groupId': 'FG003', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '85'}, {'groupId': 'FG003', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Insufficient clinical response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '32'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}, {'value': '489', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Lurasidone 40mg', 'description': 'Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.'}, {'id': 'BG001', 'title': 'Lurasidone 80mg', 'description': 'lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.'}, {'id': 'BG002', 'title': 'Lurasidone 120mg', 'description': 'Lurasidone 40 mg tablets taken once/day'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '37.7', 'spread': '11.2', 'groupId': 'BG002'}, {'value': '38.2', 'spread': '9.9', 'groupId': 'BG003'}, {'value': '38.8', 'spread': '10.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '149', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}, {'value': '340', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '271', 'groupId': 'BG004'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 489}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-05', 'studyFirstSubmitDate': '2007-10-24', 'resultsFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2007-10-25', 'lastUpdatePostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-08', 'studyFirstPostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total PANSS Score From Baseline to the End of the Double Blind Phase', 'timeFrame': '6 weeks', 'description': 'The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.'}], 'secondaryOutcomes': [{'measure': 'CGI-S From Baseline to the End of the Double-blind Treatment', 'timeFrame': '6 weeks', 'description': "Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'SM-13496', 'Latuda', 'Lurasidone'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '23421963', 'type': 'RESULT', 'citation': 'Nasrallah HA, Silva R, Phillips D, Cucchiaro J, Hsu J, Xu J, Loebel A. Lurasidone for the treatment of acutely psychotic patients with schizophrenia: a 6-week, randomized, placebo-controlled study. J Psychiatr Res. 2013 May;47(5):670-7. doi: 10.1016/j.jpsychires.2013.01.020. Epub 2013 Feb 17.'}, {'pmid': '39144777', 'type': 'DERIVED', 'citation': 'Hopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan.'}, {'pmid': '34751928', 'type': 'DERIVED', 'citation': 'Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.'}, {'pmid': '27048911', 'type': 'DERIVED', 'citation': 'Correll CU, Cucchiaro J, Silva R, Hsu J, Pikalov A, Loebel A. Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study. CNS Spectr. 2016 Oct;21(5):393-402. doi: 10.1017/S1092852915000917. Epub 2016 Apr 6.'}, {'pmid': '24955752', 'type': 'DERIVED', 'citation': 'Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be eligible to enter the study, each patient must comply with the following inclusion criteria:\n\n* Provide written informed consent and aged between 18 and 75 years of age.\n* Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.\n* Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.\n* Able and agrees to remain off prior antipsychotic medication for the duration of study.\n* Good physical health on the basis of medical history, physical examination, and laboratory screening.\n* Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.\n\nExclusion Criteria:\n\n* Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.\n* Any chronic organic disease of the CNS (other than schizophrenia)\n* Used investigational compound within 30 days.\n* Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT00549718', 'briefTitle': 'Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': 'A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'D1050229'}, 'secondaryIdInfos': [{'id': '2007-003819-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lurasidone 40mg', 'interventionNames': ['Drug: Lurasidone HCl']}, {'type': 'EXPERIMENTAL', 'label': 'Lurasidone 80mg', 'interventionNames': ['Drug: Lurasidone HCl']}, {'type': 'EXPERIMENTAL', 'label': 'Lurasidone 120mg', 'interventionNames': ['Drug: Lurasidone HCl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Pill', 'interventionNames': ['Drug: Lurasidone HCl']}], 'interventions': [{'name': 'Lurasidone HCl', 'type': 'DRUG', 'description': 'Once daily', 'armGroupLabels': ['Lurasidone 120mg', 'Lurasidone 40mg', 'Lurasidone 80mg', 'Sugar Pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72201', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'K&S Professional Research Services, LLC.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Neuroscience, Inc', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '92647', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Innovations, Inc.', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92645', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90723', 'city': 'Paramount', 'state': 'California', 'country': 'United States', 'facility': 'California Clinical Trials', 'geoPoint': {'lat': 33.88946, 'lon': -118.15979}}, {'zip': '91107', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Pasadena Research Institute', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '90660', 'city': 'Pico Rivera', 'state': 'California', 'country': 'United States', 'facility': 'California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road', 'geoPoint': {'lat': 33.98307, 'lon': -118.09673}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Mesa Vista Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Comprehensive Neuroscience, Inc.', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center, LLC', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Segal Institute for Clinical Research, Fidelity Clinical Research, Inc.', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60169', 'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Health System', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'zip': '70601', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Lake Charles Clinical Trials LLC', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '71104', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Booker, J. Gary, MD. APMC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Behavioral Health, LLC', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Downstate Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Erie County Medical Center, Corp', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CRI Worldwide LLC at Kirkbride', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Strategies of Memphis, LLC.', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Future Search Trials of Neurology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '30000', 'city': 'Nîmes', 'country': 'France', 'facility': 'Hospital Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '517507', 'city': 'Tirupati', 'state': 'Andh Prad', 'country': 'India', 'facility': 'S V Medical College', 'geoPoint': {'lat': 13.63551, 'lon': 79.41989}}, {'zip': '530017', 'city': 'Visakhapatnam', 'state': 'Andh Prad', 'country': 'India', 'facility': 'Government Hospital for Mental Care', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'zip': '380006', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Sheth Vadilal Sarabhai General Hospital', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '431005', 'city': 'Aurangabad', 'state': 'Mahara', 'country': 'India', 'facility': 'Shanti Nursing Home', 'geoPoint': {'lat': 19.87757, 'lon': 75.34226}}, {'zip': '600003', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Madras Medical College & Government General Hospital', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '221005', 'city': 'Varanasi', 'state': 'Uttar Prad', 'country': 'India', 'facility': 'Deva Mental Health Care', 'geoPoint': {'lat': 25.31668, 'lon': 83.01041}}, {'zip': '81200', 'city': 'Johor Bahru', 'state': 'Johor', 'country': 'Malaysia', 'facility': 'Hospital Permai', 'geoPoint': {'lat': 1.4655, 'lon': 103.7578}}, {'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '310022', 'city': 'Arad', 'country': 'Romania', 'facility': 'Spitalul Clinic Judetean de Urgenta Arad', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'zip': '030442', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '041914', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '130083', 'city': 'Gura Ocniței', 'country': 'Romania', 'facility': 'Centrul de Recuperare si Reabilitare Gura Ocnitei', 'geoPoint': {'lat': 44.94166, 'lon': 25.56846}}, {'zip': '110069', 'city': 'Piteşti', 'country': 'Romania', 'facility': 'Spitalul Judetean Arges', 'geoPoint': {'lat': 44.85, 'lon': 24.86667}}, {'zip': '163060', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'North State Medical University', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '111111', 'city': 'Karelia', 'country': 'Russia', 'facility': 'Republic Psychiatric Hospital'}, {'zip': '190005', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Psychoneurological Dispensary #7 (with Hospital)', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '190121', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '191119', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Psychiatric Hospital #4', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '193019', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Bekhterev Psychoneurological Research Institute', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Psychiatric Hospital #3 of Skvortsov-Stepanov', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '49005', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Dnipropetrovsk Regional Clinical Hospital named Mechnikov', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '83037', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '04080', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Kyiv City Clin. Psychoneurolog. Hosp.#1', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '79021', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '65006', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '73488', 'city': 'Vil. Stepanovka, Kherson', 'country': 'Ukraine', 'facility': 'Kherson Regional Psychiatric Hospital', 'geoPoint': {'lat': 46.63695, 'lon': 32.61458}}], 'overallOfficials': [{'name': 'Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sumitomo Pharma America, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}